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Can a shorter radiation course beat anal cancer?

NCT ID NCT07775209

Disease control Sponsor: University of Vermont Medical 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Sep 16, 2026 · Updated 3 times

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Apr 2040

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: * 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.

anal carcinoma anal squamous cell carcinoma anus neoplasm

As listed by the trial registrant

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

Anal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

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