Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
2 other identifiers
interventional
90
1 country
1
Brief Summary
The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer. This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational. Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedStudy Start
First participant enrolled
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
December 17, 2025
December 1, 2025
9 years
July 14, 2017
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Locoregional Control
Relapse defined as reappearance of tumor after complete response. If possible, relapse confirmed by biopsy.
6 months post radiation therapy
Composite Dysphagia Outcome Determined by PEG Tube Dependence at Last Follow-Up
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia. These include: 1) PEG tube dependence at last follow-up; 2) trace or frank aspiration seen on modified barium swallow study; 3) diagnosis of aspiration pneumonia; 4) presence of pharyngoesophageal structure on modified barium swallow study or endoscopy with subsequent need for dilation.
6 months post radiation therapy
Composite Dysphagia Outcome Determined by Trace or Frank Aspiration Seen on Modified Barium Swallow Study
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
6 months post radiation therapy
Composite Dysphagia Outcome Determined by Diagnosis of Aspiration Pneumonia
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
6 months post radiation therapy
Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Modified Barium Swallow Study
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
6 months post radiation therapy
Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Endoscopy with Subsequent Need for Dilation
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
6 months post radiation therapy
Secondary Outcomes (10)
Overall Survival
Start of treatment up to 5 years
Progression-Free Survival
Start of treatment up to 5 years
Distant Metastasis-Free Survival
Start of treatment up to 5 years
Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Symptom Inventory (MDASI)
Baseline up to 2 years after radiation therapy
Physician-Reported Toxicity
Weekly during radiation therapy up to 2 years after radiation therapy
- +5 more secondary outcomes
Study Arms (2)
MRI Guided Intensity Modulated Radiotherapy (IMRT)
EXPERIMENTALModified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
Standard-of-Care Intensity Modulated Radiotherapy (IMRT)
ACTIVE COMPARATORModified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
Interventions
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure to check vocal cords performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned with MRI guidance.
IMRT planned by standard-of-care.
Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
Eligibility Criteria
You may qualify if:
- Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls). Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging.
- Age ≥18 years
- Clinical stage T1-3, N0-2 (AJCC, 8th ed.), with no distant metastases, based on routine staging workup.
- Positive for HPV by p16 IHC or ISH
- Lifetime pack-year history of \<10 years, currently non-smoking for at least 5 years.
- No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
- No retropharyngeal nor level IV (or lower) lymphadenopathy (i.e. nodes in level I-III only)
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
- Dispositioned to photon/proton radiotherapy +/- chemotherapy
- For females of child-bearing age, a negative pregnancy test
You may not qualify if:
- Patients who have undergone definitive resection of their primary or nodal disease as well as any chemotherapy or radiation therapy for their HNSCC.
- 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
- Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices.
- History of claustrophobia
- Having an estimated glomerular filtration rate (GFR) \< 40ml/min/1.73m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Bahig H, Yuan Y, Mohamed ASR, Brock KK, Ng SP, Wang J, Ding Y, Hutcheson K, McCulloch M, Balter PA, Lai SY, Al-Mamgani A, Sonke JJ, van der Heide UA, Nutting C, Li XA, Robbins J, Awan M, Karam I, Newbold K, Harrington K, Oelfke U, Bhide S, Philippens MEP, Terhaard CHJ, McPartlin AJ, Blanchard P, Garden AS, Rosenthal DI, Gunn GB, Phan J, Cazoulat G, Aristophanous M, McSpadden KK, Garcia JA, van den Berg CAT, Raaijmakers CPJ, Kerkmeijer L, Doornaert P, Blinde S, Frank SJ, Fuller CD. Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL stage 2a-2b/Bayesian phase II trial. Clin Transl Radiat Oncol. 2018 Aug 24;13:19-23. doi: 10.1016/j.ctro.2018.08.003. eCollection 2018 Nov.
PMID: 30386824DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clifton Fuller, MD, PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2017
First Posted
July 21, 2017
Study Start
January 17, 2018
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 17, 2025
Record last verified: 2025-12