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Proton beam vs. X-Ray: which radiation is safer for throat cancer?

NCT ID NCT01893307

Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This phase 3 trial compares two types of radiation therapy for advanced throat cancer: standard photon radiation (IMRT) and newer proton beam therapy (IMPT). The goal is to see if proton therapy causes fewer severe side effects while still controlling the cancer. About 440 patients with stage III-IVB oropharyngeal cancer are taking part, and researchers are tracking side effects, survival, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Proton beam therapy (IMPT) and photon radiation therapy (IMRT)
What this could lead to
If successful, this could show that proton therapy is as effective as standard radiation but with fewer severe side effects, improving quality of life for throat cancer patients.
What could go wrong
This is a large phase 3 trial, but results are not yet available. Proton therapy is more expensive and less accessible, and it may not prove significantly better than standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

440 people

The number who actually took part.

Started

Aug 2013

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage III oropharyngeal squamous cell carcinoma ajcc V7 Stage IVA oropharyngeal squamous cell carcinoma ajcc V7 Stage IVB oropharyngeal squamous cell carcinoma ajcc V7

Contacts and locations

Locations

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson League City

    League City, Texas, 77573, United States

  • MD Anderson West Houston

    Houston, Texas, 77079, United States

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478, United States

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384, United States

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • New York Proton Center

    New York, New York, 10035, United States

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610, United States

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Willis-Knighton Medical and Cancer Center

    Shreveport, Louisiana, 71103, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.