Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Trial
Official title:
A Pilot Study to Evaluate the Utility of Interim Digital PET/CT in Predicting Outcomes for Locally Advanced Oropharyngeal Cancer
This trial studies how well digital PET scan works in predicting outcomes in patients with oropharyngeal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). The development of digital detectors for PET is a technological improvement in medical imaging that could potentially impact many areas of clinical oncology, including staging, radiation planning accuracy, and the assessment of treatment response. Digital technology may improve PET imaging performance by providing better timing, energy and spatial resolution, higher count rate capabilities and linearity, increased contrast, and reduced noise. Utilizing digital PET scan, may work better in predicting outcomes and treatment response in patients with oropharyngeal cancer compared to conventional PET.
PRIMARY OBJECTIVE: I. To evaluate the utility of early (i.e. during treatment) digital positron emission tomography (dPET) as a diagnostic tool to predict local control 6 months after definitive chemoradiation for patients with locally advanced oropharyngeal carcinoma. SECONDARY OBJECTIVES: I. To study the association between dynamic dPET parameters taken at early time points (i.e. during treatment) and CR on PET after definitive chemoradiation. II. To study the association between dynamic dPET parameters taken at early time points (i.e. during) treatment and 2 year local control after definitive chemoradiation. III. To assess the ability of dynamic dPET compared to conventional PET or conventional-equivalent dPET reconstruction to identify tumor volumes with greater sensitivity at the time of before (dPET1), during (dPET2, dPET3) and after (dPET4, dPET5) chemoradiation. IV. To generate preliminary data for future methodology or clinical trials. OUTLINE: Patients receive fludeoxyglucose F-18 via injection and undergo dPET over 20 minutes after standard of care computed tomography (CT) imaging (week -2), after receiving 20-26 Gy and 40-46 Gy of radiation (weeks 3 and 5), and 3 months after completion of treatment. Patients with concern for residual disease may receive an additional dPET 6 months after treatment. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05172245 -
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
|
Phase 1 | |
Completed |
NCT04489212 -
Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration in HPV+ Head and Neck Cancer of Unknown Primaries
|
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 |