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NCT01893307 · ClinicalTrials.gov registry record · Phase 3
Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer
A Phase 3 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
- 20
- Study locations
NCT01893307: Active Phase 3 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
NCT01893307 is a Phase 3 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 440 participants, above the 154-participant average among 5 other Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 trials with a reported enrollment target (186% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01893307, a Phase 3 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
- 20
- Study locations
Study 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 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.
Primary Outcome
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The methods described by Gooley will be used to estimate the cumulative incidence of late onset grade 3+ toxicity by 2 years for each treatment arm with death as a competing risk. The methods of Fine and Gray will be used to model the cumulative incidence of late onset grade 3+ toxicity by 2 years as a function of treatment arm and other potential prognostic factors
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION Photon Beam Radiation Therapy
- RADIATION Proton Beam Radiation Therapy
Study Locations (20)
Texas
- MD Anderson in The Woodlands - Conroe
- M D Anderson Cancer Center - Houston
- MD Anderson West Houston - Houston
- MD Anderson League City - League City
- MD Anderson in Sugar Land - Sugar Land
Florida
- University of Florida Health Science Center - Gainesville - Gainesville
- Miami Cancer Institute - Miami
New York
- New York Proton Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic in Arizona - Scottsdale
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Illinois
- Northwestern Medicine Cancer Center Warrenville - Warrenville
Louisiana
- Willis-Knighton Medical and Cancer Center - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2013-08-26 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 3 |
What the registry record for NCT01893307 still lists
NCT01893307 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 5 other Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 trials with a reported enrollment target (186% higher).
The record links to 3 conditions, with Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01893307 names 20 study sites across 14 states, led by Texas, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT01893307 about?
NCT01893307 is a clinical study titled "Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer". 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 ...
What is the current status of trial NCT01893307?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2013-08-26. Estimated completion is 2031-12-31.
What conditions does trial NCT01893307 study?
This clinical trial studies the following 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.
What interventions are being tested in trial NCT01893307?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Photon Beam Radiation Therapy (RADIATION), Proton Beam Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01893307?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01893307 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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