[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-cell-carcinoma-of-the-larynx\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-cell-carcinoma-of-the-larynx":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,74,99,125],{"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":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100294558","phase-1-trial-of-stereotactic-hypofractionated-radioablative-hydra-treatment-of-laryngeal-cancer-100294558",false,"NCT03114462","Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer","A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer","Inclusion Criteria:\n\n1. Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx.\n2. Stage T1N1\u002FT2-4aN0-1 disease, as defined by American Joint Committee on Cancer (AJCC) criteria.\n3. ECOG (Zubrod) performance status 0-2.\n4. Must be functionally and technically fit for partial laryngectomy. Subsite study candidates will be evaluated by enrolling physician. The assessment checklist will be submitted at time of enrollment and evaluated by Dr. Gross or Dr. Phan.\n5. 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.\n6. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: \\*Has not undergone a hysterectomy or bilateral oophorectomy; or \\*Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n7. Ability to understand English language and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n1. Patients who have undergone resection of primary disease.\n2. Patients who have received induction chemotherapy for their cancer diagnosis.\n3. Patients who have undergone a diverting tracheostomy which is either a) traversing directly through tumor, b) has been placed for true airway insufficiency. Patients with a tracheostomy placed preemptively for impending airway compromise remain eligible for enrollment.\n4. Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.\n5. Prior radiation therapy to the head and neck region.\n6. Women of childbearing potential (a woman of child-bearing potential is a reproductively mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \\[i.e., who has had menses at any time in the preceding 24 consecutive months\\]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study.\n7. Patients unable or unwilling to give written, informed consent.\n8. Severe, active co-morbidity, defined as follows: a. Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months. b. Transmural myocardial infarction within the last 6 months. c. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. d. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration. e. Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for liver function and f. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. Protocol-specific requirements may also exclude immuno-compromised patients.\n9. Exclusion #8 continued: g. History of treatment with potent immunosuppressive drugs for such conditions as post organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.\n10. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants\n11. Evidence of metastatic disease","ALL","18 Years",{"count":19,"type":20},11,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","To find the highest tolerable dose of stereotactic hypofractionated radioablation (HYDRA) radiation that can be given to patients with laryngeal cancer. The safety of this radiation will also be studied.",[26,27],"Malignant Neoplasms of Respiratory and Intrathoracic Organs","Squamous Cell Carcinoma of the Larynx",[29,30,31,32,33,34],"Malignant neoplasms of respiratory and intrathoracic organs","Squamous cell carcinoma of the larynx","Stereotactic hypofractionated radioablation","HYDRA","Questionnaires","Surveys","RECRUITING","2026-04-10",{"date":38,"type":39},"2026-04-15","ACTUAL",{"date":41,"type":39},"2017-08-09",{"date":43,"type":20},"2027-06-01",{"name":45,"class":46},"M.D. Anderson Cancer Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100518430","phase-2-de-intensification-of-postoperative-radiotherapy-in-patients-with-squamous-cell-carcinoma-of-the-head-and-neck-100518430","NCT06030440","De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck","DIREKHT2","Inclusion Criteria:\n\n1. Histologically proven squamous cell carcinoma of the oral cavity\u002Flarynx\u002Foro-or hypopharynx (except glottis cancer (pT1\u002F2pN0))\n2. Surgery of primary tumor and neck dissection performed according to predefined surgical standard\n3. Indication for postoperative radio(chemo)therapy\n4. No lymph node metastases \\> 6cm\n5. Lymph node metastases in not more than 3 lymph node level\n6. No distant metastases (cM0)\n7. Age ≥ 18 years, no upper age limit\n8. Eastern Cooperative Oncology Group (ECOG) ≤ 2\n9. Patients who understood protocol contents and are able to behave according to protocol\n10. Signed study-specific consent form prior to therapy\n11. Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications)\n\nExclusion Criteria:\n\n1. macroscopic incomplete resection R2\n2. Distant metastases (cM1)\n3. Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)\n4. Lymph node metastases in \\> 3 lymph node level\n5. pregnant or lactating\u002Fnursing women\n6. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment\n7. Any condition potentially hampering compliance with the study protocol and follow-up schedule\n8. On-treatment participation on other clinical therapeutic trials\n9. Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant\u002Finduction))\n10. Patients who have contraindication for MRI and CT with contrast agent (both)\n11. Prior (\\> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage\n12. History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease",{"count":56,"type":20},508,[58,59],"PHASE2","PHASE3","This randomized, prospective, multicenter phase II\u002FIII trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.",[62,27,63,64],"Squamous Cell Carcinoma of the Oral Cavity","Squamous Cell Carcinoma of the Hypopharynx","Squamous Cell Carcinoma of the Oropharynx","2026-03-11",{"date":67,"type":39},"2026-03-13",{"date":69,"type":39},"2024-01-26",{"date":71,"type":20},"2033-09",{"name":73,"class":46},"University of Erlangen-Nürnberg Medical School",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":47},"100497046","phase-2-fluorescence-guided-surgery-in-laryngeal--and-hypopharyngeal-cancer-a-feasibility-trial-100497046","NCT05752149","Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial","The STELLAR Trial: Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial","STELLAR","Inclusion Criteria:\n\n* Patients with biopsy-proven squamous cell Laryngeal and hypopharyngeal cancer, eligible for surgical resection of the tumor by TLE;\n* ≥ 18 years of age;\n* Written informed consent must be obtained;\n* Sufficient knowledge of the Dutch language to understand the informed consent form;\n\nExclusion Criteria:\n\n* History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent;\n* Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal, squamous cell skin carcinoma, or other head- and neck squamous cell cancer;\n* Patients pregnant or breastfeeding;\n* Patients with renal insufficiency (defined as eGFR \\\u003C 60);\n* Patients with previous kidney transplantation or a solitary functioning kidney;\n* Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors), that cannot be paused during the course of the study;\n* Patients with ASA classification of 4 or higher;\n* Patients with measured QTc of 500 ms or higher at screening;\n* Patients with laboratory abnormalities defined as:\n\n  * Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;\n  * Total bilirubin above 3 times the ULN or;\n  * Platelet count below 100 x 109\u002FL or;\n  * Hemoglobin below 4 mmol\u002FL (females) or below 5 mmol\u002Fl (males).\n* Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired or weakened immune system, caused by either a preexisting disease or concomitant medications;",{"count":83,"type":20},27,[58],"This is an open-label, single-dose, prospective clinical trial. The study comprises 2 work packages. The main objective of work package I (WP-1) is to assess feasibility of Fluorescence imaing (FLI) during total laryngectomy (TLE) and to assess the optimal dose of the cRGD-ZW800-1. Work package II (WP-II) is designed to assess whether FLI can detect and decrease tumor positive margins after a TLE.",[27,63],[88],"Tumour specific fluorescence imaging","NOT_YET_RECRUITING","2025-02-25",{"date":92,"type":39},"2025-02-26",{"date":94,"type":20},"2025-06-01",{"date":96,"type":20},"2027-03-01",{"name":98,"class":46},"Erasmus Medical Center",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":109,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100545344","head-and-neck-carcinoma-clinical-research-platform-for-molecular-and-blood-based-biomarkers-treatment-and-outcome-100545344","NCT06380686","Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome","Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based","HEAT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to understand and willing to sign written informed consent\n* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx)\n* Patients not amenable for curative treatment who receive palliative systemic treatment or best supportive care\n* Informed consent no later than four weeks after start of first-line palliative systemic treatment. For patients receiving \"best supportive care only\": no later than six weeks after diagnosis\u002Frecurrence or metastatic disease\n\nExclusion Criteria: none",{"count":108,"type":20},120,"36 Months","OBSERVATIONAL","Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent\u002Fmetastatic head and neck tumor patients.",[62,64,63,27],[114],"SCCHN","2024-11-11",{"date":117,"type":39},"2024-11-13",{"date":119,"type":39},"2024-11-07",{"date":121,"type":20},"2030-11",{"name":123,"class":46},"AIO-Studien-gGmbH",2,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":150,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100526640","phase-2-european-larynx-organ-preservation-study-elos-mk-3475-c44-100526640","NCT06137378","European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]","ELOS - Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiation Compared to Additional PD-1 Inhibition in CPS ≥1 Advanced Laryngeal\u002FHypopharyngeal Cancer Suitable for Laryngectomy Selected After Early Response Evaluation","ELOS","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male and female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of squamous cell carcinoma (SCC) of the larynx or hypopharynx according to the decision of the multidisciplinary tumor board suitable for total laryngectomy can be enrolled in this study.\n2. Stage III, IVA or IVB, whenever clear resection margins R0 \\>5 mm can be achieved and no radiologic signs of extranodal extension of neck nodes are present.\n3. Have provided newly obtained excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.\n4. PD-L1-expression\\* within the tumor biopsy, CPS ≥1\n5. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n6. Female participants:\n\n   A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n   1. Not a woman of childbearing potential (WOCBP) OR\n   2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation\u002Frandomization.\n8. Have adequate organ function as defined in the (Table 4) of the protocol. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory receptor on T or NK cells (e.g., CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-cancer therapy including investigational agents.\n4. Has received prior radiotherapy.\n5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n9. Has known distant metastases including active CNS metastases and\u002For carcinomatous meningitis.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n13. Has an active infection requiring systemic therapy.\n14. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.\n15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n16. Has a known history of active TB (Bacillus Tuberculosis).\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n20. Has had an allogenic tissue\u002Fsolid organ transplant.\n21. Has a known intolerance to one of the substances administered during treatment including e.g. antibiotics, antiemetics, etc. or any other component of concurrent auxiliary medication.","70 Years",{"count":135,"type":20},140,[58],"ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA\u002FB head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with PD-L1-expression within tumor tissue biopsy, calculated as CPS ≥ 1 curable by total laryngectomy. Induction chemotherapy (IC) with Docetaxel and Cisplatin (TP) followed by radiation will be compared to additional PD-1 inhibition. Patients will be selected after short induction early response evaluation after the first cycle IC (IC-1) aiming on larynx organ-preservation by additional 2 cycles IC followed by radiotherapy (69.6 Gy) for responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30%. Nonresponders (ETSS \\\u003C 30% or progressing disease) will receive total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation according to the recommendation of the clinics multidisciplinary tumor board. However, Patients randomized into the intervention arm starting day 1 will receive 200 mg Pembrolizumab (MK-3475) i.v. in 3-week cycle (q3w) for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.",[139,140,141,142,143,27,144,145,146,147,148,149],"Squamous Cell Carcinoma of Head and Neck","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma Stage III","Laryngeal Squamous Cell Carcinoma Stage IV","Squamous Cell Carcinoma of Larynx","Squamous Cell Carcinoma of the Larynx Stage III","Squamous Cell Carcinoma of the Larynx Stage IV","Laryngeal Squamous Cell Carcinoma","Laryngectomy; Status","Laryngeal Cancer","Laryngeal Neoplasms",[151,152,153,154,155,156,157,158,159],"induction chemotherapy","neoadjuvant treatment","immune checkpoint inhibitor","pembrolizumab","KEYNOTE","larynx organ preservation","laryngectomy-free survival","overall survival","event-free survival","2024-09-18",{"date":162,"type":39},"2024-09-20",{"date":164,"type":39},"2024-04-17",{"date":166,"type":20},"2030-12",{"name":168,"class":46},"University of Leipzig",9]