NCT01893307Active, not recruitingPhase 3
Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer
Phase III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (actual)
- First submitted
- 2 Jul 2013
- Start date
- 26 Aug 2013
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT01893307
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 440
- From 26 Aug 2013 to the primary completion date, 31 Dec 2031
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
- Previous surgical resection or neck dissection for oropharyngeal cancer, administered with therapeutic intent
Other illness
- 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
Other
- Pregnant or breast-feeding females
- Distant metastases (stage IV C, any T, any N and M1)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Maryland/Greenebaum Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Massachusetts General Hospital Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| MD Anderson in The Woodlands Coordinator of this site? Confirm its status | Conroe | United States | Unknown status |
| Wayne State University/Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Inova Schar Cancer Institute Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| University of Florida Health Science Center - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| MD Anderson West Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MD Anderson League City Coordinator of this site? Confirm its status | League City | United States | Unknown status |
| Miami Cancer Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| New York Proton Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of Pennsylvania/Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Willis-Knighton Medical and Cancer Center Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| MD Anderson in Sugar Land Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Northwestern Medicine Cancer Center Warrenville Coordinator of this site? Confirm its status | Warrenville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.