Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University Hospital/Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
University of Maryland/Greenebaum Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Massachusetts General Hospital Cancer Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
MD Anderson in The Woodlands
Coordinator of this site? Confirm its status
ConroeUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Inova Schar Cancer Institute
Coordinator of this site? Confirm its status
FairfaxUnited StatesUnknown status
University of Florida Health Science Center - Gainesville
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
MD Anderson West Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
MD Anderson League City
Coordinator of this site? Confirm its status
League CityUnited StatesUnknown status
Miami Cancer Institute
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
New York Proton Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
University of Oklahoma Health Sciences Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
University of Pennsylvania/Abramson Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Mayo Clinic in Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesUnknown status
Fred Hutch/University of Washington Cancer Consortium
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Willis-Knighton Medical and Cancer Center
Coordinator of this site? Confirm its status
ShreveportUnited StatesUnknown status
MD Anderson in Sugar Land
Coordinator of this site? Confirm its status
Sugar LandUnited StatesUnknown status
Northwestern Medicine Cancer Center Warrenville
Coordinator of this site? Confirm its status
WarrenvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.