ECOG-ACRIN E3311: Phase II Randomized Trial of Transoral Surgical Resection Followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

SUMMARY

The purpose of this study is 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 papillomavirus associated oropharynx cancer. The study is being done because we think that the results of studying your cancer under the microscope can help us be more careful about how much extra treatment needs to be given after surgery.

About 377 people in the United States will take part in this study.

Patients who have a virus associated with head and neck cancer will be asked to participate in this study.

All patients will initially be treated with transoral surgery to remove their tumor. Depending on the surgical results, some patients will not receive any extra treatment (what is referred to as observation), some will receive radiation (at one of 2 different doses of radiation) and some will receive chemotherapy and radiation.

Depending on the pathology results, you will either be observed (arm A), randomized to one of two radiation schedules that differ in terms of the total amount of radiation given (arms B or C), or treated with chemotherapy and radiation (arm D).

COH Protocol Number : 14145

ClinicalTrials.gov Number : NCT01898494

Principal Investigator : Maghami, Ellie M.D.

Sponsor : Eastern Cooperative Oncology Group (ECOG) || American College of Radiology Imaging Network (ACRIN)

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : >=18

Gender : Either

Minimum Performance Status : ECOG/SWOG:1

Treatment Intent : Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :