Trial Summary
What is the purpose of this trial?This randomized phase II/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.
Eligibility Criteria
This trial is for adults with stage III-IVB oropharyngeal cancer who can provide tumor tissue for testing. They should have an ECOG performance status of 0, 1, or 2 and be able to undergo concurrent chemotherapy and bilateral neck radiation. Pregnant women, those with recent heart issues, previous head and neck radiation within five years, distant metastases, uncontrolled major diseases or prior surgical resection for their cancer are excluded.Inclusion Criteria
I am currently receiving chemotherapy.
My cancer is a type of throat cancer called squamous cell carcinoma.
I can take care of myself and am up and about more than half of my waking hours.
I am not pregnant.
I have received radiation therapy on both sides of my neck.
Exclusion Criteria
I had radiation for head or neck cancer in the last 5 years.
I do not have uncontrolled heart, lung, kidney, liver, stomach, or blood diseases.
Treatment Details
The study compares two types of radiation therapy: intensity-modulated proton beam therapy versus intensity-modulated photon therapy. It aims to determine which method is more effective in treating patients with advanced oropharyngeal cancer while also assessing side effects and impact on quality of life.
2Treatment groups
Experimental Treatment
Group I: Arm II (IMPT)Experimental Treatment4 Interventions
Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
Group II: Arm I (IMRT)Experimental Treatment4 Interventions
Patients undergo IMRT QD five days a week for approximately 6.5 weeks.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo ClinicRochester, MN
New York Proton CenterNew York, NY
Northwestern Memorial HospitalChicago, IL
Massachusetts General Hospital Cancer CenterBoston, MA
More Trial Locations
Loading ...
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)Collaborator