[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tonsil-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tonsil-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,72,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100585458","treatment-de-escalation-for-favorable-prognosis-human-papilloma-virus-hpv-or-p16-positive-oropharyngeal-cancer-receiving-definitive-radiotherapy-100585458",false,"NCT06902623","Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy","A Phase II Study of Treatment De-Escalation for Favorable Prognosis, Stage I-II Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy","Lombardi197","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* clinical stage stage I-II (T1-2 N1 M0, or T3 N0-1 M0 ) (AJCC 8th ed.) SCCA of the oropharynx that would mandate definitive chemoradiation as current standard of care when standard radiation fractionation is applied. Debulking of the disease by resecting the exophytic portion of the tumor for biopsy\u002Fsample or symptom alleviation will be permitted, as long as gross unresected tumor is left behind.\n* Subjects must agree to biopsy of areas that are FDG-avid on PET-CT scan 3-4 months after treatment.\n* Patients must have Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration\n* Patients must have had a neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.\n* Patient must have had a hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.\n* Patients must be a current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history\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 the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients with gross involvement of level 4 lymph node level\n* Endophytic T3 disease, as clinically determined by the principal investigator.\n* Patients with any single lymph node \\> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \\>4cm is allowed)\n* Patients with nodal disease clinically fixed to or radiographically invading adjacent neck musculature any single lymph node \\> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \\>4cm is allowed)\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 undergoing active surveillance.\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The current standard treatment option for Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer is full-dose radiation combined with chemotherapy. Results with chemotherapy combined with full-dose radiation therapy leads to high rates of cure; this has called into question whether therapy can be decreased in intensity since both chemotherapy and radiation have long-term side effects. One approach to decrease intensity of treatment is to give radiation alone (excluding chemotherapy) and to decrease radiation therapy dose. The investigator believes that omitting chemotherapy and decreasing radiation dose both to tumor and the regions of the head and neck at highest risk of potential spread, may have no significant impact on the cancer recurring while potentially leading to fewer long-term side effects.",[27,28,29,30],"Oropharyngeal Cancers","HPV","Tonsil Cancer","Base of Tongue Cancer","RECRUITING","2026-04-14",{"date":34,"type":35},"2026-04-17","ACTUAL",{"date":37,"type":35},"2019-08-01",{"date":39,"type":21},"2030-12-31",{"name":41,"class":42},"Georgetown University","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100586412","cthpvdna-in-hpv-positive-squamous-cell-carcinoma-of-the-oropharynx-100586412","NCT06915038","ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx","Circulating Tumor HPV DNA Driven Adjuvant Treatment Deintensification After Transoral Surgery for HPV-Positive Squamous Cell Carcinoma of the Oropharynx","Inclusion Criteria:\n\nPre-Surgery\n\n* Subjects ≥ 18 years old at the time of informed consent.\n* Ability to provide written informed consent and HIPAA authorization.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).\n* Histopathologically confirmed squamous cell carcinoma.\n* Detectable ctHPVDNA from blood samples collected prior to treatment.\n* Resectable and accessible tumor with high probability of achieving negative margins.\n* Smokers and non-smokers included.\n* Tumor stage (AJCC 8th edition): T1 or T2, and select T3 tumors that are mobile and do not invade the larynx.\n* Nodal stage (AJCC 8th edition): N0, N1 or N2.\n* Mobile neck nodes on physical exam if N positive.\n* HPV+ tumor, as determined by p16, in-situ hybridization, real-time polymerase chain reaction, or ctHPVDNA.\n\nPost-Surgery\n\n• Subjects with unknown primaries included if primary is definitively identified and resectable with negative margins or if the palatine and lingual tonsils are thoroughly resected and pathologically proven to be negative for a primary.\n\nExclusion Criteria:\n\n* Serious medical condition preventing general anesthesia for surgery.\n* History of previous head and neck radiation or previous head and neck cancer within 3 years.\n* Distant metastatic disease present.\n* Subjects with synchronous HPV+ oropharynx primaries\n* Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study.\n* Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test on the day of surgery. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:\n\n  1. Has undergone a hysterectomy or bilateral oophorectomy; or\n  2. Has been naturally amenorrheic for at least 12 consecutive months.",{"count":52,"type":21},120,[24],"This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.",[56,57,58,29],"Squamous Cell Carcinoma of Oropharynx","HPV Positive Cancer","Throat Cancer",[60,61,28,62],"NavDX","HPVctDNA","transoral surgery","2025-07-28",{"date":65,"type":35},"2025-07-31",{"date":67,"type":35},"2025-06-11",{"date":69,"type":21},"2028-12",{"name":71,"class":42},"Indiana University",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"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":82,"type":21},60,[84],"PHASE2","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.",[87,29,58,88],"Oropharynx Cancer","Base of the Tongue Carcinoma",[90,91,92,93,94],"oropharynx cancer","throat cancer","HPV related throat cancer","tonsil cancer","base of tongue cancer","2023-10-20",{"date":97,"type":35},"2023-10-23",{"date":99,"type":35},"2018-08-14",{"date":101,"type":21},"2026-08-30",{"name":103,"class":42},"Nader Sadeghi",1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100349378","photon-therapy-versus-proton-therapy-in-early-tonsil-cancer-100349378","NCT03829033","Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.","ARTSCAN V","Inclusion Criteria:\n\n1. The patient must be at least 18 years old.\n2. Histologically or cytologically confirmed, previously untreated squamous cell carcinoma of the tonsil T1-2 (p16-positive or p16-negative) N0-1 M0 (p16-positive)\u002FN0-N2b M0 (p16-negative) according to AJCC 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent. The treatment may be followed but not preceded by surgery, which would be as a salvage procedure and not part of the planned treatment. An excision of a lymph node, or a tonsillectomy for diagnostic purposes does not exclude the patient from participation.\n3. World Health Organisation\u002FEastern Cooperative Oncology Group (WHO\u002FECOG) performance status 0-1.\n4. The patient must be able to understand the information about the treatment and give a written informed consent.\n\nExclusion Criteria:\n\n1. Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy\n2. Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years.\n3. Two or more synchronous primary cancers in the head and neck region at time of diagnosis\n4. Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator\n5. Co-existing disease prejudicing survival (expected survival should be \\>2 years).\n6. Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance\n7. When dental fillings with amalgam or metal are present close to the tumour area it must be considered if this may affect radiotherapy before inclusion.",{"count":113,"type":21},100,[24],"In this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage T1-2 (p16-positive or p16-negative) N0-1 (p16-positive)\u002FN0-N2b (p16-negative) according to American Joint Committee on Cancer (AJCC) 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent will be included. The patients will be randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional radiotherapy) versus radiotherapy with protons.",[29],[29,118,119,120,121,122,123,124,125,126,127],"Early Tonsil Cancer","Radiotherapy","Photons","Protons","Acute Side Effects","Late Side Effects","Locoregional Control","Disease Free Survival","Quality of Life","Health Economic","2021-08-31",{"date":130,"type":35},"2021-09-01",{"date":132,"type":35},"2019-01-22",{"date":134,"type":21},"2028-01",{"name":136,"class":42},"Lund University Hospital",12]