E3311 Phase II Randomized Trial of Transoral Surgical Resection followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
This research is being done to study the effects, good and/or bad of performing surgery through your mouth (what is referred to as transoral surgery) followed by treatment that is selected based on studying your cancer under a microscope by a doctor (called a pathologist), on you and your human papilloma virus associated oropharynx cancer.
Generally healthy adults with advanced head and neck cancer with the following: Associated with HPB by p16 protein expression; No prior radiation to the head or neck; No history of congestive heart failure, stroke, TIA, unstable angina, or myocardial infarction; No uncontrolled diabetes, uncontrolled infection, or uncontrolled high blood pressure; Acceptable blood tests; and Not pregnant or breastfeeding.
Consented and eligible subjects will have their transoral resection with neck dissections. They will then be randomized to one of the following groups: A) Observation, B) IMRT Radiotherapy for 25 fractions, C) IMRT Radiotherapy for 30 fractions, or D) IMRT Radiotherapy for 33 fractions with weekly cisplatin given in the arm. You will have an equal chance of being placed in one of the four arms. You and your doctor will not be able to choose. All subjects will be followed for 3 years.
09/17/2014 04:03 AM