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Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer

NCT01893307

Active Not RecruitingPhase 3

Sponsor: M.D. Anderson Cancer Center

Conditions: Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7

Interventions: Intensity-Modulated Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Photon Beam Radiation Therapy, Proton Beam Radiation Therapy

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (22)

Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Gainesville, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Warrenville, Illinois, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
New York, New York, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Conroe, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
League City, Texas, United States
Sugar Land, Texas, United States
Fairfax, Virginia, United States
Seattle, Washington, United States