Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer
NCT ID: NCT01893307
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
440 participants
INTERVENTIONAL
2013-08-26
2031-12-31
Brief Summary
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Detailed Description
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To compare the progression-free survival (PFS) between concurrent chemo-radiation strategies with IMRT and IMPT following the treatment of oropharyngeal tumors.
SECONDARY OBJECTIVES:
1. To assess and compare overall survival between IMRT and IMPT along with estimating disease-related outcomes such as: \[2-year progression-free survival, patterns of failure, 2-year overall survival, 2-year distant metastasis free survival, and second primary cancers\]
2. To assess acute and chronic/late side effects, and to compare the rates of Grade 3-5 toxicity between IMRT and IMPT following the treatment of oropharyngeal tumors.
3. To assess Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), FACT-HN, Xerostomia and Health Questionnaire (EQ-5D-3L), Work status (WPAI: SHP)
4. To assess Physician Reported Toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0
5. To evaluate and compare Quality-Adjusted-Life-Years (QALY) between IMPT and IMRT;
6. To perform Cost-benefit economic analysis of treatment;
7. To determine whether specific molecular profiles are associated with overall or progression-free survival;
8. To investigate associations between changes in blood biomarkers, or HPV-specific cellular immune responses, or HPV ctDNA (measured at baseline and three months and at each follow-up visit for up to 10 years) with overall or progression-free survival;
9. To bank peripheral blood at time of enrollment, weeks 2, 4, and 6 during treatment and at each follow up visits for up to 10 years to explore the ability of circulating markers to predict outcome;
10. To bank head and neck tissues to explore the ability of tissue-based markers to predict outcome;
11. To bank peripheral blood and tissues for future interrogations; Finally, all additional secondary endpoints
EXPLORATORY OBJECTIVE:
I. To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but were denied insurance coverage for the treatment arm she/he was randomized to; or may have dropped out of the study for other reasons after being randomized. These patients will compromise Group 3: consisting of patients randomized to Protons but not treated and Group 4: consisting of patients randomized to IMRT but not treated at the designated institution. Furthermore, these patients will only be followed for recurrence and survival.(Phase III)
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo IMRT once daily (QD) five days a week for approximately 6.5 weeks.
ARM II: Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm I (IMRT)
Patients undergo IMRT QD five days a week for approximately 6.5 weeks.
Intensity-Modulated Radiation Therapy
Undergo IMRT
Laboratory Biomarker Analysis
Correlative studies
Photon Beam Radiation Therapy
Undergo IMRT
Quality-of-Life Assessment
Ancillary studies
Arm II (IMPT)
Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
Intensity-Modulated Radiation Therapy
Undergo IMPT
Laboratory Biomarker Analysis
Correlative studies
Proton Beam Radiation Therapy
Undergo IMPT
Quality-of-Life Assessment
Ancillary studies
Interventions
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Intensity-Modulated Radiation Therapy
Undergo IMRT
Intensity-Modulated Radiation Therapy
Undergo IMPT
Laboratory Biomarker Analysis
Correlative studies
Photon Beam Radiation Therapy
Undergo IMRT
Proton Beam Radiation Therapy
Undergo IMPT
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Steven J Frank
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Willis-Knighton Medical and Cancer Center
Shreveport, Louisiana, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
New York Proton Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson in The Woodlands
Conroe, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson West Houston
Houston, Texas, United States
MD Anderson League City
League City, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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Gunn GB, Blanchard P, Garden AS, Zhu XR, Fuller CD, Mohamed AS, Morrison WH, Phan J, Beadle BM, Skinner HD, Sturgis EM, Kies MS, Hutcheson KA, Rosenthal DI, Mohan R, Gillin MT, Frank SJ. Clinical Outcomes and Patterns of Disease Recurrence After Intensity Modulated Proton Therapy for Oropharyngeal Squamous Carcinoma. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):360-367. doi: 10.1016/j.ijrobp.2016.02.021. Epub 2016 Feb 12.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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M D Anderson Cancer Center website
Other Identifiers
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NCI-2013-01879
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012-0825
Identifier Type: OTHER
Identifier Source: secondary_id
2012-0825
Identifier Type: -
Identifier Source: org_study_id
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