Can a shorter radiation course beat anal cancer?
NCT ID NCT07775209
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a shorter course of radiation therapy, given alongside standard chemotherapy, can effectively treat high-risk anal cancer. The standard treatment typically requires about 6 weeks of daily radiation, which can be a heavy burden for patients. The new approach uses a 23-fraction radiation schedule designed to be shorter while aiming to deliver a similar tumor-killing dose. The study will measure how many patients achieve a complete response at 6 months and will also track side effects and long-term outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hypofractionated radiation therapy given with standard chemotherapy (mitomycin C and capecitabine)
- What this could lead to
- If successful, this could offer a shorter, more convenient treatment option for anal cancer patients, potentially reducing the burden of daily hospital visits.
- What could go wrong
- This is an early-phase study with a small number of participants. The shorter radiation course may not control the tumor as effectively as the standard longer course, and there is a risk of increased 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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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2029
An estimate. Start dates often move.
- Expected to finish
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Apr 2040
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: * Age 18 years or older * Histologically or cytologically confirmed non-metastatic anal squamous cell carcinoma meeting one of the following criteria: T2 tumor measuring ≥4 cm T3 or T4 disease Any node-positive disease * Patients with HPV-associated (p16-positive) perianal cancer are eligible if the tumor extends to the anal verge * Karnofsky Performance Status \>60 * Creatinine clearance \>30 mL/min * Considered by the investigator to be appropriate candidates for concurrent capecitabine and mitomycin C chemotherapy * Ability to understand and willingness to provide informed consent * For participants of childbearing potential: negative pregnancy test or documented absence of pregnancy per institutional standard within 14 days prior to registration * Participants of reproductive potential must agree to use adequate contraception during study treatment and for 90 days after completion of therapy Exclusion Criteria: * Prior pelvic radiation therapy * Uncontrolled intercurrent illness that, in the opinion of the investigator, would prevent safe receipt of radiation therapy or capecitabine * Prior or concurrent malignancy that, in the opinion of the investigator, could interfere with assessment of safety or efficacy * Current receipt of another investigational agent for treatment of anal squamous cell carcinoma
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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 official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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