New trial tests shorter radiation for head and neck cancer that has returned
NCT ID NCT03164460
First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This phase II trial compares two types of radiation for people whose head and neck cancer has come back and cannot be removed with surgery. One method delivers high-dose radiation in fewer sessions, while the other uses standard daily doses over several weeks. The study aims to see which approach causes fewer severe side effects and better controls the cancer. It includes 68 participants with small tumors who have already had radiation before.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy (stereotactic body radiation therapy or intensity-modulated radiation/proton therapy)
- What this could lead to
- If successful, this trial could show that a shorter, more precise radiation treatment is safer and works as well as standard radiation for people with recurrent head and neck cancer.
- What could go wrong
- This is a small, early-phase trial that is currently suspended. It only includes people with small tumors who cannot have surgery, so results may not apply to everyone. Radiation to previously treated areas carries risks of severe side effects.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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68 people
The number who actually took part.
- Started
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May 2017
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer * Not eligible for surgery for recurrence or poor surgical candidate * Gross disease apparent on imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]) * 1-3 sites of recurrence (\< 60 cc per site, total volume \< 100 cc) * Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2 * Negative pregnancy test for women of child bearing potential Exclusion Criteria: * Patients who are pregnant or breast feeding * Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: * a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device * b) No myocardial infarction within 3 months of registration * Widely metastatic disease (oligometastatic disease acceptable)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Sharper radiation boost aims to tackle head and neck cancers that return
- Drug combo shows promise for tough head and neck cancers
- Ultrasound boosts cancer drug in tiny trial
- New triple-drug cocktail takes on hard-to-treat head and neck cancer
- New radiation technique offers hope for head and neck cancer patients with few options