Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Trial
Official title:
A Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration in HPV + Head and Neck Cancer of Unknown Primaries (HNCUP)
This clinical trial evaluates the clinical outcome of mucosal sparing adjuvant radiotherapy after surgical exploration in HPV+ head and neck cancer of unknown primaries. The purpose of this research is to assess if radiation treatment to the neck only for tumors with unclear original locations after careful surgical evaluation will lead to historical rates of disease control while reducing side effects and toxicity from treatment.
PRIMARY OBJECTIVE: I. To describe the rate of manifestation of an occult primary tumor in the pharyngeal axis or delayed nodal recurrence in a un-dissected and/or non-irradiated neck at 2 years after study registration in patients treated with mucosal sparing (and unilateral neck, if applicable) radiotherapy after resection using transoral surgery for head and neck cancer of unknown primaries (HNCUP). SECONDARY OBJECTIVES: I. To describe the rates and severity of acute and late toxicities and PEG dependence attributable to mucosal sparing radiotherapy after resection using transoral surgery by assessment of grade 3 or higher adverse events National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 criteria. II. To describe the overall survival, recurrence-free survival (manifestation of an occult primary in the pharyngeal axis, nodal recurrence in a treated (surgery/radiation therapy [RT]) neck, delayed lymph node metastasis in an untreated neck (surgery/RT), and distant failure associated with mucosal sparing radiotherapy. III. To describe swallowing function changes (assessed via swallowing study) associated with transoral surgery and adjuvant mucosal sparing radiotherapy. OUTLINE: Patients who have recurrence or progression during treatment or observation have medical charts reviewed every 6 months for 5 years. Patients who complete adjuvant treatment are followed for observation 3 days after radiation therapy, 1 month after radiation therapy, every 3 months after radiation therapy for 2 years, every 6 months for 1 year, and then annually for 2 years. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05172245 -
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
|
Phase 1 | |
Withdrawn |
NCT04140513 -
Digital PET Scan for the Prediction of Outcomes in Patients With Locally Advanced Oropharyngeal Cancer
|
N/A | |
Terminated |
NCT03618134 -
Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner
|
Phase 1/Phase 2 | |
Suspended |
NCT04162873 -
Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
|
Phase 2 | |
Recruiting |
NCT06356272 -
Oropharynx (OPX) Biomarker Trial
|
||
Recruiting |
NCT05232851 -
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04576091 -
Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer
|
Phase 1 | |
Recruiting |
NCT04900623 -
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
|
Phase 2 | |
Active, not recruiting |
NCT04920344 -
Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy
|
Phase 2 | |
Terminated |
NCT04106362 -
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma
|
Phase 2 | |
Recruiting |
NCT05541016 -
Blood-Based Biomarkers to Inform Treatment and Radiation Therapy Decisions for HPV Associated Oropharyngeal Squamous Cell Head and Neck Cancers
|
Phase 2 | |
Recruiting |
NCT05136196 -
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
|
Phase 2 | |
Recruiting |
NCT03010150 -
Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
|
||
Recruiting |
NCT04533750 -
Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
|
Phase 1 | |
Recruiting |
NCT03811015 -
Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer
|
Phase 3 | |
Active, not recruiting |
NCT03258554 -
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
|
Phase 2/Phase 3 |