Active — Not RecruitingPhase 3

Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer

United States440 participantsStarted 2013-08-26

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically documented squamous cell carcinoma of the oropharynx (American Joint Committee on Cancer \[AJCC\] version \[v\]7 stage III-IV A,B) * 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: * Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity) * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative incidence of late onset grade 3+ toxicity anytime (Phase II)

Timeframe: Up to 2 years

Cumulative incidence of acute grade 3+ toxicity (Phase II)

Timeframe: Up to 2 years

Overall survival (OS) (Phase II)

Timeframe: Up to 5 years

Overall survival (Phase III)

Timeframe: Up to 5 years

Progression-free survival (Phase III)

Timeframe: Up to 3 years

Trial details

NCT IDNCT01893307

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-12-31

View on ClinicalTrials.gov More Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cumulative incidence of late onset grade 3+ toxicity anytime (Phase II)

Timeframe: Up to 2 years

Cumulative incidence of acute grade 3+ toxicity (Phase II)

Timeframe: Up to 2 years

Overall survival (OS) (Phase II)

Timeframe: Up to 5 years

Overall survival (Phase III)

Timeframe: Up to 5 years

Progression-free survival (Phase III)

Timeframe: Up to 3 years