Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer
Running, not enrolling · Phase 3
Conditions studied: Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
In brief
This randomized phase III trial studies the side effects and how well intensity-modulated proton beam therapy works and compares it to intensity-modulated photon therapy in treating patients with stage III-IVB oropharyngeal cancer. Radiation therapy uses high-energy x-rays, protons, and other types of radiation to kill tumor cells and shrink tumors. It is not yet known whether intensity-modulated proton beam therapy is more effective than intensity-modulated photon therapy in treating oropharyngeal cancer.
Key facts
- Study ID
- NCT01893307
- Run by
- M.D. Anderson Cancer Center
- People needed
- 440
- Starts
- 2013-08-26
- Expected to finish
- 2031-12-31
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically documented squamous cell carcinoma of the oropharynx (American Joint Committee on Cancer [AJCC] version [v]7 stage III-IV A,B)
- Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or p16 (in situ hybridization [ISH], immunohistochemistry [IHC] or genotyping testing); if you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing
- Eastern Cooperative Oncology Group (ECOG) performance status = 0, 1, or 2
- Negative pregnancy test for women of child bearing potential
- Concurrent chemotherapy
- Bilateral neck radiation
You may not qualify if…
- Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
- Pregnant or breast-feeding females
- Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
- Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
- Myocardial infarction within 3 months of registration
- Distant metastases (stage IV C, any T, any N and M1)
- Previous surgical resection or neck dissection for oropharyngeal cancer, administered with therapeutic intent
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States
- University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
- Miami Cancer Institute — Miami, Florida, United States
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
- Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
- Willis-Knighton Medical and Cancer Center — Shreveport, Louisiana, United States
- University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
- Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
- New York Proton Center — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States
- MD Anderson in The Woodlands — Conroe, Texas, United States
- M D Anderson Cancer Center — Houston, Texas, United States
- MD Anderson West Houston — Houston, Texas, United States
- MD Anderson League City — League City, Texas, United States
- MD Anderson in Sugar Land — Sugar Land, Texas, United States
- Inova Schar Cancer Institute — Fairfax, Virginia, United States
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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