Status:
ACTIVE_NOT_RECRUITING
Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 stag...
Detailed Description
PRIMARY OBJECTIVES: To compare the progression-free survival (PFS) between concurrent chemo-radiation strategies with IMRT and IMPT following the treatment of oropharyngeal tumors. SECONDARY OBJECTI...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2031
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT01893307
Start Date
August 26 2013
End Date
December 31 2031
Last Update
August 8 2025
Active Locations (22)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
3
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610
4
Miami Cancer Institute
Miami, Florida, United States, 33176