This phase II trial studies how well magnetic resonance imaging-guided intensity modulated radiotherapy works in treating participants with human papillomavirus positive oropharyngeal cancer. Magnetic resonance imaging-guided intensity modulated radiotherapy may help doctors visualize tumor and soft tissue involvement in participants with oropharyngeal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT03224000.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the safety, feasibility and non-inferiority of magnetic resonance image (MRI)-guided dose adaptation for the treatment of low risk human papilloma virus positive (HPV+) oropharyngeal cancer (OPC) using a novel Phase II Bayesian two-stage adaptive design compared to the conventional intensity modulated radiotherapy (IMRT).
SECONDARY OBJECTIVES:
I. To measure the reductions in normal tissue toxicity and post-radiotherapy quality of life decrement from an MRI-guided dose adaptation strategy as compared to a conventional IMRT group.
II. To assess disease-related outcomes (2-year progression-free survival, distant metastasis-free survival, and overall survival) in both treatment groups.
III. To compare the patterns of failure in both groups.
IV. To validate functional imaging kinetics as a correlate of early treatment response.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants undergo MRI simulation in weeks 1, 2, 3, and 4 and intensity-modulated radiation therapy (IMRT) once daily, 5 days a week (Monday-Friday), for up to 33 treatments. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT, and blood sample collection throughout study.
GROUP II: Participants receive standard of care IMRT once daily, 5 days a week (Monday-Friday), for up to 33 treatments. Patients also undergo CT, PET/CT, and blood sample collection throughout study.
After completion of study treatment, participants are followed up every 2 weeks for 8-12 weeks, and then periodically thereafter.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorClifton David Fuller