[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oropharynx-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oropharynx-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,85,122,151,173,211,243,269,295,327,352,376,403,427,467,491,522,550,579,603,630],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":47,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983",false,"NCT05686226","E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers","A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically or cytologically confirmed metastatic or refractory\u002Frecurrent HPV-16+ cancer.\n2. Tumor and\u002For blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease as assessed by RECIST Criteria Version 1.1.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.\n7. Must have received prior first line standard therapy or have declined standard therapy.\n8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).\n9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.\n10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.\n13. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate transferase (AST) (SGOT)\u002Falanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol.\n15. Participants must be able to understand and be willing to sign the written informed consent document.\n16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Participants may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n\n    Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.\n14. Current treatment with another investigational agent.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Cervical Cancer","Throat Cancer","Oropharynx Cancer","Anal Cancer","Vulva Cancer","Vaginal Cancer","Penile Cancer","Metastatic Cancer","HPV-Related Malignancy","HPV-Related Carcinoma","HPV-Related Cervical Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Associated Vaginal Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Endocervical Adenocarcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV Positive Rectal Squamous Cell Carcinoma",[48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"Chimeric antigen receptors (CAR-T)","Tumor infiltrating lymphocyte","TCR-T","immunotherapy","T cell","adoptive cell therapy","cellular therapy","gene therapy","human papillomavirus","HPV","E7","T cell receptor","TCR","E7 TCR","lymphocyte","cell therapy","cervical cancer","oropharyngeal cancer","anal cancer","vulvar cancer","vaginal cancer","penile cancer","tumor infiltrating lymphocytes (TIL)","TIL therapy","RECRUITING","2026-06-10",{"date":75,"type":76},"2026-06-12","ACTUAL",{"date":78,"type":76},"2023-03-07",{"date":80,"type":20},"2027-01-01",{"name":82,"class":83},"Christian Hinrichs","OTHER",3,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100488427","phase-1-e7-t-cell-receptor-tcr--t-cell-induction-therapy-for-locoregionally-advanced-hpv-associated-cancers-100488427","NCT05639972","E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers","A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.\n2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.\n7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n9. Seronegative for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative.\n10. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate aminotransferase (AST) (SGOT)\u002F alanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n11. Participants must be able to understand and be willing to sign the written informed consent document.\n12. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) for biospecimen studies.\n\nNote: Patients may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted.\n2. Current treatment with another investigational agent.\n3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n5. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible.\n6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n7. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated.\n8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.",{"count":93,"type":20},15,[95,23],"PHASE1","The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival.\n\nThis study seeks to determine 1) if E7 TCR-T cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and 5 years.\n\nParticipants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.",[98,35,34,39,38,41,37,43,44,45,42,26,28,29,99,32,31],"HPV-Associated Cervical Carcinoma","Vulvar Cancer",[57,101,102,103,104,105,106,49,60,52,107,108,109,110,111,112,113,114],"Cell therapy","Adoptive cell therapy","Immunotherapy","Radiation","Chemoradiation","CAR-T, cell therapy","Gene therapy","Cervical cancer","Oropharyngeal cancer","Anal cancer","Vulvar cancer","Vaginal cancer","Penile cancer","Induction therapy",{"date":75,"type":76},{"date":117,"type":76},"2025-08-11",{"date":119,"type":20},"2026-10-01",{"name":82,"class":83},2,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100559379","phase-2-personalized-volume-deescalated-elective-nodal-irradiation-in-oropharyngeal-head-and-neck-squamous-cell-carcinoma-100559379","NCT06563362","Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma","Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck","DeEscO","Inclusion Criteria:\n\n* Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.\n* Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes.\n* Age ≥ 18 years, no upper age limit.\n* ECOG performance score \\\u003C 3.\n* History\u002Fphysical examination within 30 days prior to study inclusion by head and neck surgeon and\u002For radiation oncologist.\n* FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory.\n* Participants need to provide informed consent.\n\nExclusion Criteria:\n\nInclusion Criteria:\n\n* Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.\n* Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes.\n* Age ≥ 18 years, no upper age limit.\n* ECOG performance score \\\u003C 3.\n* History\u002Fphysical examination within 30 days prior to study inclusion by head and neck surgeon and\u002For radiation oncologist.\n* FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory.\n* Participants need to provide informed consent.\n\nExclusion Criteria:\n\n* Multilevel primary tumors extending unambiguously beyond the oropharynx into the oral cavity, naso- or hypopharynx\n* Distant metastases detected.\n* Previous surgery, chemotherapy or radiotherapy treatment for other head and neck cancers.\n* Previous surgery in head and neck region affecting the cervical lymphatic system. Dissection of singular lymph nodes for diagnostic purposes before treatment start is allowed.\n* Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or intermediate- risk prostate cancer or breast with a progression-free follow-up time of at least 3 years without any remaining disease burden, or other previous malignancy with a progression-free interval of at least 5 years without any remaining active\u002Fprogressive disease burden regardless whether the treatment is completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy for prostate cancer).\n* Pregnancy or breast feeding\n* Any severe mental or psychic disorder affecting decision making and ability to provide informed consent.",{"count":131,"type":20},120,[23],"Multicentric prospective model-based de-escalation of the elective clinical target volumes (CTV) in radiotherapy of oropharyngeal carcinoma of all stages with the goal to reduce toxicity.\n\nThe study investigates the feasibility of this approach as measured by the number of expected out-of-field recurrencies based on the individual patient's state of disease progression and risk factors",[28],[136,137,138,139,140],"head and neck cancer","radiotherapy","elective CTV","clinical target volume","de-escalation","2026-05-28",{"date":143,"type":76},"2026-06-01",{"date":145,"type":76},"2025-02-04",{"date":147,"type":20},"2030-02-28",{"name":149,"class":83},"University of Zurich",6,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100500770","phase-2-lymphoscintigraphy-directed-elective-neck-radiation-for-p16-favorable-risk-oropharynx-cancer-100500770","NCT05800574","Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer","A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation","Inclusion Criteria:\n\n* Pathologically confirmed squamous cell carcinoma of the oropharynx\n* Patients to be treated with bilateral neck radiation per current guidelines must have either present (see below):\n* Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8th ed.): N0 (provided the tumor is within 1cm of midline) N1\\> 1 lymph nodes (on the same side of the neck as the primary cancer) or cN3 (cranial nerve III) with no contralateral neck adenopathy\n* Tumor stage T1-2 that approaches within 1 cm but does not cross midline as appreciated radiographically and\u002For by the treating radiation oncologist or a head and neck surgeon\n* CT with contrast and\u002For MRI with contrast performed within 56 days prior to registration that does not demonstrate bilateral neck adenopathy. In the setting of medical contraindication to both CT and MRI contrast please contact the study PI\n* PET\u002FCT performed with 28 days prior to registration that does not demonstrate bilateral neck adenopathy.\n* Immunohistochemical staining for p16 that demonstrates moderate to severe staining in at least 70% of cells.\n* Patients must provide their smoking history prior to registration. Number of pack-years = \\[Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)\\]\u002F20\n* Patients must have clinically and\u002For radiographically evident disease that can be accurately measured in accordance with RECIST criteria v. 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 56 days prior to registration\n* Age ≥ 18 years.\n* Adequate hematologic function within 14 days prior to registration\n* Adequate renal function within 14 days prior to registration\n* Adequate hepatic function within 14 days prior to registration\n\nExclusion Criteria:\n\n* Tumors that cross midline, regardless of T stage\n* N2 adenopathy (bilateral neck adenopathy)\n* Gross total excision of the primary site in a diagnostic procedure prior to either imaging and\u002For physical examination by registering physician.\n* p16-negative squamous cell carcinoma\n* Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles\n* Prior systemic therapy for the study cancer\n* Prior head and neck cancer surgery that involved the neck (includes excisional biopsy)\n* Prior radiation therapy to the head and neck that would result in overlap of treated fields\n* History of allergic reaction attributed to Technetium-99m-tilmanocept used in lymphoscintigraphy\n* Uncontrolled intercurrent illness including, but not limited to, any other malignancy, other ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breast feeding",{"count":159,"type":20},22,[23],"This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck.",[28],"2026-05-20",{"date":165,"type":76},"2026-05-22",{"date":167,"type":76},"2023-03-14",{"date":169,"type":20},"2027-09-23",{"name":171,"class":83},"Fox Chase Cancer Center",1,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":172},"100592718","phase-2-methotrexate-erlotinib-and-celecoxib-for-the-treatment-of-recurrentmetastatic-head-and-neck-cancer-in-a-rural-midwest-united-states-population-100592718","NCT06997068","Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent\u002FMetastatic Head and Neck Cancer in a Rural Midwest United States Population","MC240701 Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent\u002FMetastatic Head and Neck Cancer in a Rural Midwest United States Population","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed diagnosis of relapsed\u002Fmetastatic head and neck cancer, including oral cavity, oropharynx \\[human papillomavirus (HPV) positive and negative), hypopharynx, and larynx cancer\n* Measurable or non-measurable disease is allowed\n\n  * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n  * Non-measurable disease\n\n    * NOTE: Other nonmeasurable lesions include clinically evident lesions not well visualized on imaging \\[e.g., oral cavity mass readily seen on physical exam but obscured on computed tomography (CT)\\], dermal metastases, and bone metastases\n* Prior treatment:\n\n  * One of the following must be true:\n\n    * Received standard 1st-line immunotherapy or chemo-immunotherapy OR\n    * Unable to receive or refuse 1st-line therapy\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained 15 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained 15 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin per Chronic-Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation (obtained 15 days prior to registration)\n* Estimated creatinine clearance (Clcr) by the CKD-EPI Creatinine Equation (per National Kidney Foundation) (obtained 15 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Ability to swallow pills\n* Willing and able to adhere with the protocol schedule for the duration of the study including undergoing treatment, attending scheduled visits, and examinations\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Myocardial infarction ≤ 6 months prior to registration\n  * New York Heart Association (NYHA) class III or IV heart failure\n  * Corrected QT interval (QTc) prolongation more than 440 ms in males and 460 ms in females\n  * Uncontrolled dysrhythmias or poorly controlled angina\n  * History of serious ventricular arrhythmia \\[ventricular tachycardia (VT) or ventricular flutter (VF)\\] and\u002For factors that predispose to arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome)\n  * Ongoing or active infection requiring systemic treatment\n  * Active gastrointestinal bleeding\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Known hepatitis\n\n  * Exception: For patients with evidence of chronic hepatitis B virus infection the hepatitis B (HepB) viral load must be undetectable on suppressive therapy, if indicated, to be eligible\n  * Exception: Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with hepatitis C virus (HCV) infection who are currently on treatment are eligible if they have an undetectable HCV viral load\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy. Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria\n\n  * NOTE: Patients with secondary malignancy with life expectancy ≥ 2 years are eligible\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens",{"count":181,"type":20},25,[23],"This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving the combination of methotrexate, erlotinib, and celecoxib may be feasible, safe, and effective in treating rural Midwest patients with recurrent\u002Fmetastatic head and neck cancer.",[185,186,187,188,189,28,190,191,192,193,194,195,196,197,198,199,200,201],"Metastatic Oral Cavity Carcinoma","Recurrent Oral Cavity Carcinoma","Stage IVC Lip and Oral Cavity Cancer AJCC v8","Head and Neck Cancer","Hypopharynx Cancer","Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Metastatic Hypopharyngeal Carcinoma","Metastatic Laryngeal Carcinoma","Metastatic Malignant Head and Neck Neoplasm","Metastatic Oropharyngeal Carcinoma","Recurrent Hypopharyngeal Carcinoma","Recurrent Laryngeal Carcinoma","Recurrent Malignant Head and Neck Neoplasm","Recurrent Oropharyngeal Carcinoma","Stage IVC Hypopharyngeal Carcinoma AJCC v8","Stage IVC Laryngeal Cancer AJCC v8","Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8","2026-05-07",{"date":204,"type":76},"2026-05-11",{"date":206,"type":76},"2025-07-09",{"date":208,"type":20},"2028-06-30",{"name":210,"class":83},"Mayo Clinic",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":21,"phases":221,"briefSummary":223,"conditions":224,"keywords":227,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100570373","phase-3-lymphocyte-sparing-and-radio-immunotherapy-in-head-and-neck-carcinoma-100570373","NCT06706401","Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma","A Multicenter, Randomised 2*2 Factorial Design Comparing Standard to Reduced-target Volume Radiotherapy With or Without All-trans Retinoic Acid (ATRA) in Patients With Lateralised Oropharyngeal, Laryngeal and Hypopharyngeal Squamous Cell Carcinoma.","LYSARI","Inclusion criteria :\n\nI1. Male or female patients aged ≥ 18 years old at time of inform consent signature.\n\nI2. Patients with primary head and neck tumour up to, but not crossing the midline, previously untreated with histologically-confirmed squamous cell carcinoma of:\n\n* the oropharynx p16-, larynx or hypopharynx : T1\u002FN2a-N2b, T2\u002FN0-N2b, T3\u002FN0-N2b (UICC 8th Ed.), or\n* the oropharynx p16+ : T1\u002FN1 (multiple nodes), T2-T3\u002FN0-N1 (UICC 8th Ed.).\n\nI3. Patients with lymph node staging assessed by an FDG-PET\u002FCT with no contralateral nodal uptake.\n\nI4. Patients amenable to treatment with RT or concomitant chemo-radiotherapy as decided by the treating physician as a function of tumor stage, tumor location, performance of the patients.\n\nI5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n\nI6. Adequate hematologic and end-organ function, defined by the following laboratory test results obtained within 7 days prior to randomisation :\n\nHematological (without transfusion within 2 weeks) :\n\n* Neutrophils count \\> 1.5 × 109 \u002FL\n* Platelets count \\> 75 × 109 \u002FL\n* WBC≥ 3.0 × 109 \u002FL\n\nHepatic function :\n\n* Total Bilirubin \\\u003C 1.5 × ULN (except for Gilbert's syndrome which will allow bilirubin ≤ 3 ULN).\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n* Aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n* Albumin \\>3.0g\u002FdL\n\nRenal function :\n\n* Serum creatinine \\\u003C 1.5 ×ULN.\n\nI7. QTcF ≤450ms for men and 470ms for women, from 3 electrocardiograms on screening ECG, within 7 days prior randomisation.\n\nI8. Women patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy test within 7 days prior randomisation, and agrees to use adequate contraception for up to 1 month after the end of study treatments.\n\nI9. Fertile men must agree to use an effective method of contraception during the study and for up to 1 month after the end of study treatments.\n\nI10. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.\n\nI11. Patients must be covered by a medical insurance in country where applicable.\n\nExclusion criteria :\n\nE1. Patient with primary tumor crossing the midline or patients with bilateral primary tumors.\n\nE2. Patients with T1-N0 (p16-), T1-N1 (p16-), T1-N0 (p16+), T4 (p16- and p16+), bilateral lymph nodes or nodal disease more than 6 cm (p16- and p16+).\n\nE3. Patients with unknown primary tumor size as per TNM i.e. T0-N1 to T0-N3, p16- or p16+.\n\nE4. Patients with contralateral FDG-PET\u002FCT nodal uptake.\n\nE5. Patient with any previous anti-cancer therapy for HNSCC (all prior treatment are forbidden: chemotherapy, radiotherapy, targeted therapy, immunotherapy or any other therapy approved or experimental).\n\nE6. Patient with malignancies other than HNSCC within 3 years prior to randomisation with the exception of adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localised prostate cancer treated surgically with curative intent.\n\nE7. Patient with ongoing or anticipation of need for systemic immunosuppressive medication (including, but not limited to, glucocorticoids, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents); with the exceptions of intranasal, inhaled or topical corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid.\n\nE8. Patient with ongoing or anticipation of need for systemic immunostimulatory agents (including, but not limited to, interferons and IL-2).\n\nE9. Patient with concurrent treatment with any other anti-cancer treatment, approved or investigational agent or participation in another clinical trial with therapeutic intent.\n\nE10. Patient with infectious diseases :\n\n* Severe infection within 4 weeks prior to randomisation, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,\n* Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening),\n* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening,\n* HIV infection,\n* Active tuberculosis.\n\nE11.Patient with any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nE12. Patient with known hypersensitivity to tretinoin, other retinoids, soya, peanut or to any of the excipients of vesanoid.\n\nE13. Patient with known malabsorption syndrome and\u002For unable to swallow oral medication.\n\nE14.Patient with ongoing or expected need for concomitant treatment with vitamin A, tetracyclines, other retinoids, anti-fibrinolytic agent, and strong inducers or inhibitors of CYP3A4.\n\nE15.Pregnant or lactating woman.",{"count":220,"type":20},460,[222],"PHASE3","The aim of this study is to investigate the effect of ATRA (Vesanoid) and the effect of tailored radiotherapy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx.",[28,225,189,226],"Larynx Cancer","Primary Head and Neck Tumor",[228,229,230,231,232],"Localised squamous cell carcinoma of head and neck","Previously untreated","Standard radiotherapy","Tailored radiotherapy","Vesanoid","2026-04-21",{"date":235,"type":76},"2026-04-24",{"date":237,"type":76},"2025-02-20",{"date":239,"type":20},"2029-01",{"name":241,"class":83},"Centre Leon Berard",8,{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":242},"100462919","phase-2-a-study-on-using-cell-free-tumor-dna-ctdna-testing-to-decide-when-to-startroutine-treatment-in-people-with-human-papilloma-virus-hpv--associated-oropharynx-cancer-opc-100462919","NCT05307939","A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)","Phase II Trial Evaluating Selective Minimal Residual Disease Directed Adjuvant Radiation in Human Papilloma Virus Associated Oropharynx Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18\n* ECOG 0-2\n* HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary . HPV status must be confirmed by in-situ hybridization.\n* HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies\u002FmL pre-operatively.\n* Surgical resection of all gross disease with no gross disease visualized on post-operative imaging.\n\n  o For patients with pT0 (unknown primary) evaluation for the primary should include PET\u002FCT, direct laryngoscopy, ipsilateral tonsillectomy, and targeted biopsy. This should be followed by a neck dissection.\n* Two, undetectable (\\\u003C1 copy\u002FmL) post-operative HPV ctDNA within 2-6 weeks following surgery (blood drawn at least one week apart preferred).\n* A minimum of one of the following pathologic criteria: (Arm A)\n\n  * AJCC 7 Stage: pT0N1-N2b, pT1N1, pT2N1, or ≥pT3\n  * AJCC 7 ≥pN2\n  * Lymphovascular invasion\n  * Perineural invasion\n  * Close pathologic margin (≤ 3 mm)\n* Signed informed consent form by the participant or their legally authorized representative (LAR).\n* A minimum of one of the following pathologic criteria (Arm B):\n\n  * Microscopic positive margin\n  * Extracapsular extension\n* Signed informed consent form by the participant or their legally authorized representative (LAR).\n\nAdditional criteria for Arm B only:\n\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * White Blood Count (WBC) ≥ 2 K\u002FmcL\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 8.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula:\n  * CCr male = \\[(140 - age) x (wt in kg)\\] divided by \\[(Serum Cr mg\u002Fdl) x (72)\\]\n  * CCr female = 0.85 x (CrCl male)\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  \\- Bilirubin \\\u003C 2 mg\u002Fdl o AST or ALT \\\u003C 3 x the upper limit of normal\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n\nExclusion Criteria:\n\n* Metastatic disease\n* Non-HPV16 genotype (i.e. HPV-18,-31, -33, -35)\n* Patients who receive surgery at outside institution. Exceptions can be made for high-volume surgical centers at the discretion of the PI\u002Fco-PI\n* Prior head and neck radiation\n* Patients without pre-operative HPV ctDNA or pre-operative HPV ctDNA ≤ 50 copies\u002FmL\n* Subjects with simultaneous primary cancers outside of the oropharynx\n\n  o Note: Exceptions can be made for patients with simultaneous primaries outside of the oropharynx if determined by the PI\u002FCo-PI, then the patient can proceed with protocol activities\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater\n\n  o Note: Exceptions can be made for patients with prior invasive malignancy if determined by the PI\u002FCo-PI, then the patient can proceed with protocol activities\n* Prior systemic chemotherapy for the study cancer\n\n  o Note: prior chemotherapy for a different cancer is allowable\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n* Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.",{"count":251,"type":20},30,[23],"This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery.\n\nIn Arm A the researchers will see whether monitoring participants' HPV ctDNA levels can safely identify patients who do not need radiation therapy (RT) after surgery and whose RT can be delayed until their HPV ctDNA levels become detectable.\n\nIn Arm B, the researchers will see whether patients who usually need 6-6.5 weeks of CRT can be selected by HPV ctDNA to receive 3 weeks of CRT.",[57,28,35,34,39],[256,257,258,259,260],"ctDNA","NavDx test","21-434","HPV-OPC","Memorial Sloan Kettering Cancer Center","2026-04-10",{"date":263,"type":76},"2026-04-13",{"date":265,"type":76},"2022-03-24",{"date":267,"type":20},"2027-03-24",{"name":260,"class":83},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":276,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":278,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":172},"100558671","de-escalation-of-adjuvant-radiation-for-low-risk-hpv-oropharyngeal-cancers-100558671","NCT06554158","De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers","A Phase II Study of Post-Resection Radiation Dose and Treatment Site De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age on the day of signing informed consent.\n* Patients must have a diagnosis of p16+ and\u002For HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and\u002For posterior oropharyngeal wall).\n* pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site.\n* Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.\n* neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.\n* hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.\n* current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history\n* start radiation within 8 weeks of resection (6 weeks preferable)\n* have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Perineural invasion at primary site\n* Lymphovascular space invasion at primary site\n* Level 4 nodal involvement (even if resected)\n* Retropharyngeal nodal involvement (even if resected)\n* any intact, unresected disease\n* nodal disease pathologically invading adjacent neck musculature\n* Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy\n* Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate cancer that is undergoing active surveillance.\n* Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma",true,{"count":251,"type":20},[279],"NA","The goal of this clinical trial is to learn whether for intermediate-risk patients who have undergone Transoral Robotic Surgery for HPV\u002Fp16(+) oropharyngeal cancer and have minimal smoking history, whether these patients can be treated with a lower-than standard dose, with omission of the primary site in the oropharynx. The main questions it aims to answer are:\n\nDoes radiotherapy site and dose-de-escalation lead to similar outcomes compared to historical data on tumor control in patients who are treated with standard radiation doses and treatment fields?\n\nParticipants will:\n\nUndergo treatment with a lower than standard radiation dose (50Gy in 25 fractions, with either Intensity Modulated Radiation Therapy (IMRT) or proton beam therapy) and to a smaller than standard radiation field (to the neck only, excluding the original site of tumor in the oropharynx)",[28],[57,283,284,285,65],"tonsil","base of tongue","soft palate","2026-03-19",{"date":288,"type":76},"2026-03-23",{"date":290,"type":76},"2019-08-01",{"date":292,"type":20},"2028-12-31",{"name":294,"class":83},"Georgetown University",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":21,"phases":304,"briefSummary":305,"conditions":306,"keywords":315,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100597801","phase-2-a-study-of-sacituzumab-govitecan-in-combination-with-cetuximab-in-people-with-head-and-neck-squamous-cell-cancer-hnscc-100597801","NCT07063212","A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)","A Phase II Study of Sacituzumab Govitecan in Combination With Cetuximab in Patients With Recurrent Metastatic HNSCC That Has Progressed After First-Line Therapy","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck arising from the sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, and larynx. Other sites not listed will be subject to PI discretion.\n\n  * Advanced disease (Stage IV or M1 disease) not amenable to curative local therapy with surgery and\u002For radiation based approaches\n  * Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial\n  * HPV status for oropharynx primary must be previously confirmed or can be performed on available archival or fresh biopsy via p16 immunohistochemistry or HPV specific testing via PCR or RNA ISH. Patients are able to enroll and initiate treatment so long as this is in progress. Exceptions may be made after discussion and review with P.I.\n  * Have measurable disease per RECIST v1.1 criteria. Tumor lesions situated in previously radiated area may be utilized if they are measurable and progression has been demonstrated in these lesions.\n* Male or female patients 18 years of age or older on the day of consent.\n* ECOG Performance Status of 0 to 1.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g\u002Fdl is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  o Serum creatinine \\\u003C 2.0 x upper limit of normal (ULN) or creatinine clearance (CCr)\n\n  ≥ 30 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] CCr female = 0.85 x (CrCl male)\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN.\n  * AST and ALT \\\u003C 2.5 x the upper limit of normal\n  * Albumin ≥ 3 g\u002FdL\n* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.\n* Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.\n* Female patients are eligible to participate if they are not pregnant, not breastfeeding and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential\n  * A woman of childbearing potential who agrees to use highly effective contraception from signing of the ICF through six months after the last study treatment administration.\n\nNotes:\n\ni. Female of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>1 year. ii. Highly effective contraception methods include:\n\n* Total abstinence\n* Male or female sterilization\n* Combination of any 2 of the following categories (Categories 1+2, 1+3, or 2+3):\n\n  * Category 1: Use of oral, injected, or implanted hormonal methods of contraception.\n  * Category 2: Placement of an intrauterine device or intrauterine system.\n  * Category 3: Category 3: Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n  * A female participant who is of childbearing potential must have a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test within 72 hours prior to the first administration of study treatment or be surgically\u002Fbiologically sterile (hysterectomy or bilateral oophorectomy) or postmenopausal. Note: Postmenopausal females are defined as those who are:\n* Age \\> 50 years with amenorrhea for ≥ 12 months.\n* Age ≤ 50 years with six months of spontaneous amenorrhea and follicle stimulating hormone level within postmenopausal range (\\> 40 mIU\u002FmL).\n\n  * Male patients must agree to use contraception and refrain from sperm and egg donation from the time period between signing of the ICF and through five months after the last dose of study drug\n  * The subject must provide voluntary study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Patients must not have received more than 2 prior line of systemic treatment (i.e. in the second or third line of treatment) in the recurrent\u002Fmetastatic setting.\n\n  o Ambiguity regarding lines of treatment a patient has received will be subject to PI review and approval.\n* Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge based on assessment by PI and\u002For consultation with allergy\u002Fimmunology.\n* Patients who have previously received topoisomerase I inhibitors for HNSCC\n* Patients who have a confirmed or suspected diagnosis (subject to P.I. discretion) of Gilbert's Syndrome\n* Have had a prior anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.\n* Have not recovered (ie, ≤ Grade 1) from AEs due to a previously administered agent.\n\n  * Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are exceptions to this criterion and may qualify for the study.\n  * Note: If subjects underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study drug.\n  * Note: Subjects with Grade ≤ 2 immune-mediated toxicities (except colitis which must be recovered, \\\u003C Grade 1) related to immunotherapy and\u002For radiation treatment that are long lasting, but stable on treatment and not requiring agents that are excluded by this protocol may qualify for the study.\n* Patients with simultaneous primary cancers aside from HNSCC will be excluded unless otherwise approved by PI.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate for the malignancy treated at 5 years is estimated to be 90% or greater, unless otherwise approved by PI\n* Severe, active co-morbidity defined as the following:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute infection requiring intravenous therapy at the time of registration\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n  * Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defect\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, no evidence of new or enlarging brain metastases and are taking ≤ 20 mg\u002Fday of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), immune-mediated colitis, or gastrointestinal (GI) perforation within 6 months of C1D1.\n* Known acquired immunodeficiency syndrome due to untreated\u002Fpoorly controlled human immunodeficiency virus. Other diagnosed immunodeficiency syndromes or disorders will require the review and approval of the site PI.\n* Positive test for hepatitis B surface antigen (HBsAG) or hepatitis C virus antibody (anti-HCV), indicating acute or chronic infection. Patients who test positive for anti-HCV but negative for HCV ribonucleic acid (RNA) are permitted to enroll.\n* Herbal remedies known to potentially interfere with major organ function within 28 days prior to the first dose of study treatment, unless agreed otherwise between the PI and treating investigator.\n* Female patients who are pregnant, breastfeeding, or plan on becoming pregnant during the study.",{"count":303,"type":20},40,[23],"The purpose of this study to find out whether sacituzumab govitecan in combination with cetuximab is an effective and safe treatment approach for people with recurrent and\u002For metastatic head and neck squamous cell cancer (HNSCC).",[307,308,309,310,28,189,225,311,312,313,314,39],"Squamous Cell Carcinoma of Head and Neck","Sinus Cancer","Nasal Cavity Cancer","Oral Cavity Cancer","Oral Squamous Cell Carcinoma","Oropharynx Squamous Cell Carcinoma","Hypopharynx Squamous Cell Carcinoma","Larynx Squamous Cell Carcinoma",[307,308,309,310,28,189,225,311,312,313,314,39,316,317,260],"Sacituzumab Govitecan","25-094","2026-02-17",{"date":320,"type":76},"2026-02-19",{"date":322,"type":76},"2025-07-02",{"date":324,"type":20},"2028-01-02",{"name":260,"class":83},7,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":276,"sex":16,"minAge":333,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":21,"phases":336,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100595487","prevalence-of-human-papillomavirus-hpv-in-a-healthy-population-a-feasibility-study-of-oropharyngeal-cancer-screening-100595487","NCT07033091","Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening","Inclusion Criteria:\n\n* Participants aged 40 years or older at the time of enrollment.\n* Individuals who are capable of rinsing the oral cavity by gargling independently.\n* Signed informed consent for study participation, molecular-genetic testing, and personal data processing.\n\nExclusion Criteria:\n\n\\- Previously diagnosed head and neck cancer.","40 Years",{"count":335,"type":20},20000,[279],"This study defines the prevalence of oral infection with high-risk human papillomaviruses (hrHPV) in individuals over 40 years of age in the Czech Republic. It also establishes an effective methodology for oropharyngeal carcinoma screening and optimization of screening and testing procedures.",[28],[340,341,65],"Human Papillomavirus","HPV Infection","2026-02-11",{"date":344,"type":76},"2026-02-13",{"date":346,"type":76},"2025-06-01",{"date":348,"type":20},"2031-03-30",{"name":350,"class":83},"The Institute of Molecular and Translational Medicine, Czech Republic",5,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":375},"100500199","multi-site-trial-of-navigation-vs-treatment-as-usual-to-improve-initiation-of-timely-adjuvant-therapy-100500199","NCT05793151","Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy","A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults With Head and Neck Cancer","ENDURE","Inclusion Criteria:\n\n1. Age \\>\u002F= 18 years\n2. Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity\n3. American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or \\>N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary.\n4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT.\n5. Plan for curative intent surgery at one of the participating centers\n6. Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI).\n\nExclusion Criteria:\n\n1. Inability to speak or read English or Spanish.\n2. Severe mental illness that would prevent trial participation.\n3. HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN \\\u003C 3 cm\n4. Synchronous untreated malignancy expected to impact life expectancy",{"count":361,"type":20},532,[279],"The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are:\n\n1. Does ENDURE improve initiation of timely PORT relative to treatment as usual?\n2. What are the mechanisms through which ENDURE improves timeliness to treatment?\n3. What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?",[188,365,28,310,225],"Head and Neck Squamous Cell Carcinoma","2025-12-04",{"date":368,"type":76},"2025-12-11",{"date":370,"type":76},"2023-10-30",{"date":372,"type":20},"2028-03-30",{"name":374,"class":83},"Medical University of South Carolina",4,{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":351},"100522881","phase-2-selective-adjuvant-therapy-for-hpv-mediated-oropharynx-sccs-based-on-residual-circulating-tumor-dna-levels-saval-100522881","NCT06088381","Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)","A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)","SAVAL","Inclusion Criteria\n\n1. Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or p16+ squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.\n2. Does the patient have clinical stage T0-3, N0-N1, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET\u002FCT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET\u002FCT) with imaging within 60 days of enrollment?\n3. Has the patient completed a ctDNA evaluation with results demonstrating positive ctDNA levels prior to surgery either in blood or on biopsy tissue?\n4. Upon multi-disciplinary review, is the patient a candidate for TORS based on evaluation by ear, nose, throat (ENT) and review at multi-disciplinary tumor board?\n5. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?\n6. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?\n7. Is the patient ≥ 18 years of age?\n8. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.\n9. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?\n\nExclusion Criteria\n\n1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?\n2. Does the patient have distant metastasis?\n3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low\u002Fintermediate risk prostate cancer) unless disease free for a minimum of 3 years?\n4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?\n5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?\n6. Did the patient have prior cancer related surgeries of the head and neck excluding superficial removal of cutaneous skin malignancies?\n7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?\n8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?\n9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?",{"count":385,"type":20},61,[23],"Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment.\n\nThe goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.",[188,365,28,312,39],[390,188,28,391,392,393],"Transoral Robotic Surgery (TORS)","HPV p16 Oropharynx Cancer","Proton Therapy","Photon Therapy","2025-11-05",{"date":396,"type":76},"2025-11-10",{"date":398,"type":76},"2024-03-07",{"date":400,"type":20},"2030-12-18",{"name":402,"class":83},"University of Maryland, Baltimore",{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":21,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":375},"100497482","evaluation-of-the-benefit-of-a-new-surgical-procedure-according-to-ideal-recommendations-for-orl-cancer-patients-the-external-pudendal-flap-used-as-a-new-free-flap-for-oral-cavityoropharyngeal-reconstruction-to-limit-donor-site-sequelae-100497482","NCT05757817","Evaluation of the Benefit of a New Surgical Procedure According to IDEAL Recommendations for ORL Cancer Patients: the External Pudendal Flap Used as a New Free Flap for Oral Cavity\u002FOropharyngeal Reconstruction to Limit Donor Site Sequelae","LAMBEAU STEPA","Inclusion Criteria:\n\n1. Patient with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx.\n2. Patient whose disease is classified UICC TNM stade (8th edition) : T0-4a N0\u002FN2c M0 (no distant metastasis M0).\n3. Patient whose oral cavity or oropharynx reconstruction requires a free fasciocutaneous flap according to an experienced oncology surgeon.\n4. Patient OMS 0-1.\n5. Age ≥ 18.\n6. Patient with no contraindication to surgery.\n7. Patient affiliated to a Social Health Insurance in France.\n8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Patient with history of prior cervical surgery and\u002For radiation to the head and neck.\n2. History of pelvic surgery and\u002For radiation to the pelvic area.\n3. Patients with a contraindication to any form of sedation.\n4. Patient with irreversible coagulopathy.\n5. Patient with a contraindication to a CT scan or an injection of iodinated contrast medium.\n6. Patient with active autoimmune disorders requiring immunosuppressive therapy, defined as receiving steroids (dose \\> 10 mg of prednisone or equivalent) or other immunosuppressive therapy.\n7. Pregnant or breastfeeding women.\n8. Patient with another co-existing malignancy at the time of inclusion or any other significant medical, psychiatric, or surgical condition currently not controlled by treatment, which may interfere with the conduct of the study.\n9. Patient with diabetes (type 1 or 2).\n10. Patient with a BMI \\> 30kg\u002Fm².\n11. Any psychological, family, geographic or sociological condition that does not allow for compliance with the medical follow-up and\u002For procedures provided for in the study protocol .\n12. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).",{"count":303,"type":20},[279],"This is a phase 1b, multicenter, non-randomized prospective study involving an innovation phase (IDEAL-1) followed by a prospective development phase (IDEAL-2A) designed to evaluate the safety and feasibility of oral\u002Foropharyngeal reconstruction with the external pudendal free flap in two groups of patients.\n\nA maximum of 40 patients (20 patients per group) will be included in this IDEAL-1\u002F2A phase study.\n\nStage IDEAL-1: Innovation phase. The main objective is to evaluate the feasibility in terms of limiting surgical complications of a STEPA flap reconstruction in two groups of patients (Cohort: Male, Female).\n\nStage IDEAL-2A: Prospective development phase. The main objective is to describe the complication profile of the surgical procedure in these two patient populations.\n\nEach patient will be followed during 12 months after the end of complete treatment (surgery ± adjuvant treatment).\n\nA complementary study (observational study) of 250 patients will also be conducted to evaluate the acceptability of the technique (reconstruction by external pudendal flap) by the patients and to describe the factors associated with this acceptability.",[188,310,28],[188,310,28,415,416,417],"STEPA flap","Oropharyngeal or oral cavity reconstruction","IDEAL Recommendations","2025-09-11",{"date":420,"type":76},"2025-09-15",{"date":422,"type":76},"2023-11-08",{"date":424,"type":20},"2027-01",{"name":426,"class":83},"Institut Claudius Regaud",{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":21,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":172},"100469128","phase-2-transoral-surgical-resection-followed-by-de-escalated-adjuvant-imrt-in-resectable-p16-locally-advanced-oropharynx-cancer-100469128","NCT05388773","Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer","Phase II Trial of Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer","Inclusion Criteria:\n\n* ECOG performance status of 0 or 1 or Karnofsky score 80-100.\n* Preference is to register patients prior to surgery. However, if not registered prior to surgery, the patient can be registered prior to adjuvant therapy.\n* Patients must have newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx. Patients must have been determined to have resectable oropharyngeal disease. Patients with primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine are not eligible.\n* Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies. Metastatic disease may be evaluated using CT or PET\u002FCT where appropriate; this can be performed with or without contrast. The following imaging is acceptable to evaluate the primary and regional disease:\n\n  * CT Neck (with contrast preferred but not required)\n  * PET\u002FCT\n  * MRI Neck (contrast preferred but not required)\n* Patients must have biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node. It is required that patients have a positive p16 IHC (as surrogate for HPV) status from either the primary tumor or metastatic lymph node.\n* Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory. Using p16 antibody obtained from Roche mtm laboratories AG (CINtec, clone E6H4) is recommended.\n* No prior radiation above the clavicles.\n* Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and\u002For non- melanomatous skin cancer.\n* Patients with the following within the last 6 months prior to registration must be evaluated by a cardiologist and\u002For neurologist prior to entry into the study.\n\n  * Congestive heart failure \\> NYHA Class II\n  * CVA\u002FTIA\n  * Unstable angina\n  * Myocardial infarction (with or without ST elevation)\n* Patients must have acceptable renal and hepatic function within 4 weeks prior to registration\n\n  o For patients stratified following surgery and to concurrent chemotherapy (Arm CRT), calculated creatinine clearance must be \\> 60 ml\u002Fmin using the Cockcroft-Gault formula\n* In patients with a contraindication to cisplatin, carboplatin can be used at time of patient enrollment if they are allocated to ARM CRT.\n\nExclusion Criteria:\n\n* No evidence of extensive or \"matted\u002Ffixed\" pathologic adenopathy on preoperative imaging.\n* Patients must not need a microvascular (free flap) reconstruction. Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* Patient must not have an intercurrent illness likely to interfere with protocol therapy or prevent surgical resection\n* Patients must not have uncontrolled diabetes, uncontrolled infection despite antibiotics, or uncontrolled hypertension within 30 days prior to registration.",{"count":435,"type":20},150,[23],"This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.",[28],[440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457],"Papillomavirus Infections","Carcinoma, Squamous Cell","Oropharyngeal Neoplasms","Papilloma","Neoplasms, Glandular and Epithelial","Pharyngeal Neoplasms","Otorhinolaryngologic Neoplasms","Head and Neck Neoplasms","Pharyngeal Diseases","Stomatognathic Diseases","Otorhinolaryngologic Diseases","DNA Virus Infections","Tumor Virus Infections","Antineoplastic Agents","Intensity Modulated Radiotherapy","Carboplatin","Cisplatin","Transoral Surgery","2025-06-18",{"date":460,"type":76},"2025-06-19",{"date":462,"type":76},"2022-07-20",{"date":464,"type":20},"2030-12-31",{"name":466,"class":83},"Heath Skinner",{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":11,"sex":16,"minAge":475,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":21,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":172},"100539852","dose-adjusted-chemoradiotherapy-in-hpv-associated-oropharynx-cancer-of-the-elderly-100539852","NCT06309225","Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly","Pilot Feasibility Trial of Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly (DACHOC-E)","(DACHOC-E)","Inclusion Criteria:\n\n* Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)\n* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.\n* P16-positive based on local site immunohistochemical tissue staining\n* Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)\n* Age ≥ 65.\n* Normal organ and marrow function within 14 days prior to registration defined as follows:\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN)\n* AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN\n* Serum creatinine ≤ 1.5× ULN\n\nExclusion Criteria:\n\n* Metastatic disease\n* Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries\n* Synchronous double primaries\n* Prior radiotherapy for lymphoma or other malignancy\n* Prior systemic therapy including immunotherapy\n* Severe active comorbidity where life expectancy is \\\u003C1 year.\n* Autoimmune disease\n* Uncontrolled HIV","65 Years","99 Years",{"count":19,"type":20},[279],"Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.\n\nFor this reason this study is looking at a different regimen of reducing the intensity of the treatment.\n\nThe purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.",[28,481],"Frailty","2025-05-19",{"date":484,"type":76},"2025-05-22",{"date":486,"type":76},"2025-05-15",{"date":488,"type":20},"2026-09-30",{"name":490,"class":83},"Omar Mahmoud",{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":21,"phases":501,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":121},"100376181","phase-3-stereotactic-boost-and-short-course-radiation-therapy-for-oropharynx-cancer-100376181","NCT04178174","Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer","Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase III Trial","SHORT-OPC","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.\n* Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)\n* Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.\n* Primary tumor \\\u003C 30 cc\n* Planned for curative chemoradiation\n* For females of child-bearing age, a negative pregnancy test\n\nExclusion Criteria:\n\n* Clinical N3 classification, as per AJCC 8th edition\n* Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature\u002Ffixation to adjacent structures on clinical examination, cranial nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction).\n* Previous irradiation of the head and neck region\n* Previous surgery of the HNC region (except for incisional or excisional biopsies)\n* Pregnancy or breastfeeding\n* Connective tissue disease\n* Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.\n* Non-Cisplatin concurrent chemotherapy\n* Prior induction chemotherapy",{"count":500,"type":20},360,[222],"This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.",[188,28,504],"Human Papilloma Virus",[506,507,508,509,510,511,512],"head and neck cander","Oropharynx cancer","Human papilloma virus","Radiotherapy","Stereotactic body radiotherapy","Chemotherapy","De-intensification","2025-05-14",{"date":515,"type":76},"2025-05-18",{"date":517,"type":76},"2020-02-23",{"date":519,"type":20},"2029-12",{"name":521,"class":83},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":16,"minAge":475,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":531,"phases":4,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":549},"100465202","special-care-patterns-for-elderly-hnscc-patients-undergoing-radiotherapy-100465202","NCT05337631","Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy","SENIOR","Inclusion Criteria:\n\n* definitive (chemo-)radiotherapy of locoregionally advanced (cT3-4 and\u002For cN+) head-and-neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx\n* primary treatment since 2005\n* age ≥65 years at the time of (chemo-)radiotherapy\n\nExclusion Criteria:\n\n* adjuvant (chemo-)radiotherapy\n* history of previous head-and-neck cancers or radiotherapy in the head-and-neck region\n* distant metastases at (chemo-)radiotherapy initiation (cM1)\n* HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary",{"count":530,"type":20},1500,"OBSERVATIONAL","The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.",[534,310,28,189,225],"HNSCC",[536,509,511,537,456,538,539],"Elderly","Chemoradiotherapy","Cetuximab","Real-world data","2025-03-24",{"date":542,"type":76},"2025-03-25",{"date":544,"type":76},"2021-06-01",{"date":546,"type":20},"2026-12-31",{"name":548,"class":83},"University Hospital Freiburg",18,{"id":551,"slug":552,"hasResults":11,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":558,"targetDuration":560,"studyType":531,"phases":4,"briefSummary":561,"conditions":562,"keywords":567,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":172},"100567034","arabic-pro-measures-for-head-and-neck-cancer-radiotherapy-100567034","NCT06662929","Arabic PRO Measures for Head and Neck Cancer Radiotherapy.","Arabic Patient-reported Outcome Measures During Radiotherapy for Head and Neck Cancer: a Validation Study","PROMs","Inclusion Criteria:\n\n* Adults aged 18 or above and who is planned for receiving and who is currently receiving and who had already received radiotherapy for the HNC at King Saud University Medical City.\n\nExclusion Criteria:\n\n* Individuals who are less than 18 years, presence of debilitating disease (e.g. heart failure) or who lack the capacity to read, understand and sign the informed consent and those.",{"count":559,"type":20},125,"2 Weeks","The goal of Arabic patient-reported outcome measures during radiotherapy for head and neck cancer is to test the patient-reported outcome measure (PROM) tools. PROM tools are not validated cross-culturally in Arabic-speaking patient populations, which limits their use in our clinical setting. Validation of these PROM tools will allow clinicians to identify the concerns related to our patient population and measure the outcome of our interventions. Main objectives are:\n\n* To further validate (cross-culture) the PROM instruments related to head and neck cancer (HNC) in Arabic patients.\n* To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.\n\nThe participants will be given tasks to complete 6 tools survey before, during, and after radiotherapy.",[188,447,365,28,563,564,565,566],"Nasopharyngeal Cancer","Oral Cancer","Tongue Cancer","Oral Neoplasm",[556,188,509,568,569],"COSMIN","Cancer","2024-10-26",{"date":572,"type":76},"2024-10-29",{"date":574,"type":76},"2023-05-01",{"date":576,"type":20},"2025-10-01",{"name":578,"class":83},"King Saud University",{"id":580,"slug":581,"hasResults":11,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":21,"phases":589,"briefSummary":590,"conditions":591,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":172},"100396650","phase-2-testing-less-intensive-radiation-with-chemotherapy-to-treat-low-risk-patients-with-hpv-positive-oropharyngeal-cancer-100396650","NCT04444869","Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer","Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx \"ENID\"","ENID","Inclusion Criteria:\n\n* Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.\n* Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).\n* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.\n* Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.\n* Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:\n\n  * General history and physical examination within 30 days prior to registration;\n  * Fiberoptic exam with laryngopharyngoscopy (mirror and\u002For fiberoptic and\u002For direct procedure) within 60 days prior to registration;\n  * One of the following combinations of imaging is required within 45 days prior to registration:\n\n    1. A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast);\n    2. or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast);\n    3. or a CT scan of neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast);\n    4. or an MRI of the neck (with contrast) and a PET\u002FCT of neck and chest (with or without contrast).\n\nNote: A CT scan of neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as both staging and planning tools.\n\n* Patients will be asked about their personal smoking history prior to enrollment. Only active smokers with greater than 10 pack years will be excluded from the trial. The total number of pack years will be collected at baseline. Current smokers who wish to discontinue will be offered smoking cessation information, and if they are able to discontinue smoking prior to initiation of radiation therapy, they can remain eligible for the trial.\n\nNumber of pack-years = \\[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\\] \u002F 20 Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined.\n\n* Zubrod Performance Status of 0-1 within 30 days prior to registration;\n* Adequate hematologic function within 14 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3;\n  * Platelets ≥ 100,000 cells\u002Fmm3;\n  * Hemoglobin ≥ 8.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable.\n* Adequate renal function within 14 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin\n* Adequate hepatic function within 14 days prior to registration defined as follows:\n\n  * Bilirubin \\\u003C 2 mg\u002Fdl;\n  * AST or ALT \\\u003C 3 x the upper limit of normal.\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n\nExclusion Criteria:\n\n* Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;\n* Carcinoma of the neck of unknown primary site origin (even if p16 positive);\n* T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.\n* Radiographically matted nodes, that span 6 cm or more; N3 disease\n* Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;\n* Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;\n* Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.\n* Simultaneous primary cancers or separate bilateral primary tumor sites;\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n  * Transmural myocardial infarction within the last 6 months;\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.11 of the protocol.",{"count":588,"type":20},28,[23],"This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.",[592,28,39,593],"Cancer of the Head and Neck","Throat Carcinoma","2024-05-16",{"date":596,"type":76},"2024-05-17",{"date":598,"type":76},"2020-09-28",{"date":600,"type":20},"2026-06",{"name":602,"class":83},"University of Missouri-Columbia",{"id":604,"slug":605,"hasResults":11,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":21,"phases":612,"briefSummary":613,"conditions":614,"keywords":619,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":121},"100431678","phase-2-adaptive-radiotherapy-for-oropharynx-cancer-100431678","NCT04901234","Adaptive RadioTherapy for OroPharynx Cancer","Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial","ART-OPC","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent.\n* Stage T3-T4N0-3 as per AJCC 8th edition\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.\n* Planned for curative radiotherapy +\u002F- chemotherapy\n* For females of child-bearing age, a negative pregnancy test\n* Patients treated with induction chemotherapy can be included if they have residual tumor in place.\n\nExclusion Criteria:\n\n* Previous irradiation of the head and neck (HNC) region, excluding superficial radiation therapy for non-melanomatous skin cancer\n* Previous surgery of the HNC region (except for incisional or excisional biopsies)\n* Pregnancy or breastfeeding\n* Connective tissue disease\n* Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.\n* Patients with contra-indications to MRI will be excluded.",{"count":131,"type":20},[23],"This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. The primary objective is to compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care.",[28,615,616,617,618],"Radiotherapy; Complications","Radiotherapy Side Effect","Dysphagia","MRI",[507,509,620,621],"Adaptation","Magnetic resonance imaging","2023-12-11",{"date":624,"type":76},"2023-12-12",{"date":626,"type":76},"2021-07-30",{"date":628,"type":20},"2026-12",{"name":521,"class":83},{"id":631,"slug":632,"hasResults":11,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":638,"enrollmentInfo":639,"targetDuration":4,"studyType":21,"phases":641,"briefSummary":642,"conditions":643,"keywords":646,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":172},"100383837","phase-2-neoadjuvant-chemotherapy-and-transoral-robotic-surgery-for-oropharyngeal-cancer-100383837","NCT04277858","Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.","Phase II Study: Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Definitive Management of Oropharyngeal Squamous Cell Carcinoma. (NECTORS Trial)","NECTORS","Inclusion Criteria:\n\n* Squamous cell cancer of oropharynx, p 16 positive\n* American Joint Commission on Cancer version-7 (AJCC-7) Stage III (T1N1, T2N1, T3N0, T3N1) and stage IVa (T1N2, T2N2, T3N2)\n* Treatment Naive\n* No evidence of distant metastatic disease\n* Fit for surgery, and primary tumor assessed surgically resectable with negative margins via transoral approach\n* Age \\> 18 years\n* Karnofsky performance status \\> 60% or Eastern Cooperative Oncology Group (ECOG) \\\u003C 2\n* Absolute neutrophil count (ANC) \\> 2,000, platelets \\> 100,000 and calculated creatinine clearance \\> 50 cc\u002Fmin\n* Signed study specific consent form\n* No other malignancies except cutaneous basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the last 5 years\n* Agree to use effective contraception while on the study. Women of child bearing potential must have a negative pregnancy test, and not be lactating.\n\nExclusion Criteria:\n\n* Patients with advanced T4 cancer unresectable without organ preservation\n* P16 negative tumor\n* N3 disease (Stage IVB AJCC-7)\n* 5 or more positive cervical lymph nodes at presentation\n* Distant metastatic disease (Stage IVC)\n* Radiological evidence of gross extracapsular nodal tumor invasion\n* Anatomy not allowing transoral access and exposure\n* Prior head and neck cancer at any time (Other than BCC or SCC of skin)\n* Coexistent second malignancy or history within 5 years of prior malignancy (other than BCC or early SCC skin or curatively treated Stage I carcinoma of cervix)\n* Peripheral neuropathy \\>\u002F= grade 1\n* Have had prior Taxanes or Cisplatin\n* Concurrent infection\n* Coexisting medical illness of a severity that might interfere with treatment or follow-up, or who do not have the ability to give informed consent.\n* Receiving any other investigational agent while on the study","80 Years",{"count":640,"type":20},60,[23],"The objective of this trial is to study the efficacy of treatment of human papilloma virus (HPV) related oropharyngeal cancer with chemotherapy followed by Transoral Robotic Surgery (TORS) as definitive treatment. Current treatment of oropharyngeal cancer are chemo-radiotherapy. There is significant lifelong side effects associated with this approach related to tissue effects of radiotherapy. The side effects results in significant quality of life deterioration among the patients. Overall there is 20% failure rate with this treatment approach. The study hypothesis is that treatment with upfront (neoadjuvant) chemotherapy followed by transoral surgery and neck dissection is highly effective treatment allowing competitive cure rate compared to chemo-radiotherapy with less than 10% failure rate, while avoiding radiotherapy in majority of cases. It is also hypothesized that better functional and quality of life outcome maybe achieved with this approach.",[28,644,27,645],"Tonsil Cancer","Base of the Tongue Carcinoma",[647,648,649,650,651],"oropharynx cancer","throat cancer","HPV related throat cancer","tonsil cancer","base of tongue cancer","2023-10-20",{"date":654,"type":76},"2023-10-23",{"date":656,"type":76},"2018-08-14",{"date":658,"type":20},"2026-08-30",{"name":660,"class":83},"Nader Sadeghi"]