A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-stage, P16-positive, Non-smoking Associated Oropharyngeal Cancer

Protocol No
NRG-HN005
Principal Investigator
Musaddiq Awan
Phase
II/III
Summary
The first part of this study is being done to answer the following question: Does a reduced dose of radiation along with chemotherapy or immunotherapy result in the same length of time without your cancer getting worse as the usual approach? We are doing this study because we want to find out if this approach is the same as or worse than the usual approach for your type of cancer. The usual approach is defined as the care most people get for HPV positive oropharyngeal cancer. If the study approach is the same as the usual approach, the study will advance to the second part, the phase III, and you may be asked to participate in the second part of the study. If you are asked to participate in the second part of the study, at that time you will be asked to sign a different consent form for the phase III. The second part of this study is being done to answer the following questions: Does a reduced dose of radiation along with chemotherapy or immunotherapy result in the same length of time without your cancer getting worse as the usual approach? Is quality of life better with a reduced dose of radiation with chemotherapy or immunotherapy than the usual approach? We are doing this study because we want to find out if this approach is the same as or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for HPV positive oropharyngeal cancer.
Description
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
Participating Institutions
St. Joseph's Hospital - West Bend
Froedtert Hospital
Community Memorial Hospital
Status
OPEN TO ACCRUAL
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