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Brief Title: Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer
Official Title: Phase II Randomized Trial of Transoral Surgical Resection Followed by Low-Dose or Standard-Dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Study ID: NCT01898494
Brief Summary: This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet known how much extra treatment needs to be given after surgery.
Detailed Description: PRIMARY OBJECTIVES: I. Accrual, risk distribution, and surgical quality will be used to determine the feasibility of a prospective multi-institutional study of transoral surgery for HPV positive (+) oropharynx cancer followed by risk-adjusted adjuvant therapy. II. To assess the oncologic efficacy following transoral resection and adjuvant therapy in patients determined to be at "intermediate risk" after surgical excision, the 2-year progression free survival (PFS) rate will be examined. SECONDARY OBJECTIVES: I. To estimate the patient distribution with various histologic risk features. II. To assess and compare early and late toxicities associated with transoral surgery (TOS) and the different doses of adjuvant postoperative radiotherapy (PORT). III. To evaluate swallowing function before and after TOS and risk-adjusted adjuvant therapy. IV. To evaluate quality of life (QOL), swallowing perception and performance, voice outcomes, and head and neck symptoms. TERTIARY OBJECTIVES: I. To correlate tumor TP53 mutation and other associated mutation profile with pathologic findings, with PFS and other outcome parameters in patients with resectable HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) after the above treatments. II. To evaluate radiation resistance markers, including excision repair cross complementing 1 (ERCC1) single nucleotide polymorphism and protein expression, and correlate them with treatment efficacy. III. To investigate the usefulness of biomarkers in predicting progression-free survival and biomarkers, including tumor ERCC1, epidermal growth factor receptor (EGFR), plasma cytokine/chemokines, cellular immunity to HPV, and oral HPV deoxyribonucleic acid (DNA). OUTLINE: All patients undergo transoral surgery (TOS) in Step 1. ARM S: Patients undergo transoral resection of the oropharyngeal tumor. Then patients are classified by risk status (low risk, intermediate risk, or high risk) in Step 2 and assigned to the appropriate treatment group. Patients classified as intermediate risk are randomized to arms B or C. ARM A (low risk; observation): Patients receive observation. ARM B (intermediate risk): Patients undergo low-dose (50Gy) intensity modulated radiation therapy (IMRT) once daily (QD) over 25 fractions. ARM C (intermediate risk): Patients undergo standard-dose (60Gy) IMRT QD over 30 fractions. ARM D (high risk): Patients receive IMRT at 66 Gy QD for 33 fractions. Patients also receive cisplatin intravenously (IV) over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 year.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Kaiser Permanente Oakland-Broadway, Oakland, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Yale University, New Haven, Connecticut, United States
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Florida Hospital Orlando, Orlando, Florida, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Boston Medical Center, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
University of New Mexico, Albuquerque, New Mexico, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
PinnacleHealth Cancer Center-Community Campus, Harrisburg, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Sentara Cancer Institute at Sentara CarePlex Hospital, Hampton, Virginia, United States
Sentara Hospitals, Norfolk, Virginia, United States
Sentara Virginia Beach General Hospital, Virginia Beach, Virginia, United States
University of Washington Medical Center, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Zablocki Veterans Administration Medical Center, Milwaukee, Wisconsin, United States
Name: Robert Ferris
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR