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Could less radiation be better for anal cancer? new trial aims to find out

NCT ID NCT05902533

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a lower dose of radiation to nearby lymph nodes can reduce side effects in people with anal cancer who are also receiving chemotherapy. The trial includes 33 adults with locally advanced anal cancer. The goal is to see if this approach lowers toxicity while still controlling the disease.

What this could mean

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

Active substance
Radiation (reduced dose to lymph nodes) combined with chemotherapy drugs capecitabine and mitomycin C
What this could lead to
If successful, this could lead to a new standard of care that reduces painful side effects from radiation for anal cancer patients.
What could go wrong
This is a small, early-phase trial with only 33 participants, so results may not apply to everyone. Lowering radiation might also reduce its ability to control the cancer.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 33 people

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

Started

Aug 2023

Expected to finish

Aug 2029

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: 1. Age ≥18 years. 2. Patients must have stage T1-4N+M0 or T3/T4N0M0 locally advanced anal cancer as evidenced by a PET scan AND either a CT with contrast of the abdomen/pelvis or an MRI with contrast of the pelvis. All imaging must be from within 60 days prior to registration. 1. Note: Patients with T2N0 disease will be allowed if the primary tumor is \>4 cm. Patients with Stage I-T1N0M0 or Stage II-T2N0M0 (tumor ≤ 4cm) will be ineligible for participation. 2. Patients with perianal cancer that is HPV associated (P16+) will be eligible if the tumor extends to the anal verge and the CTV will include the mesorectal, internal/external iliac, and inguinal lymph nodes. 3. Patients with excision of the primary tumor but with node positive disease or residual disease at the primary if T3T4N0 will be eligible. 3. ECOG performance status 0 or 1 (or Karnofsky ≥70, see Appendix A). 4. Patients must be able to receive concurrent treatment with capecitabine and Mitomycin C in the opinion of the investigator. 5. Creatinine Clearance must be \> 30 ml/min. 6. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Any prior pelvic radiation. 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine. 3. Patients with uncontrolled intercurrent illness that in the opinion of the investigator would prevent receipt of radiation or capecitabine. a. Note: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 4. Pregnant or breastfeeding women are excluded from this study. 5. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator. 6. Patients with active autoimmune or connective tissue disease requiring systemic treatment are excluded from this study.

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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.

Contacts and locations

Locations

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Vermont

    Burlington, Vermont, 05405, United States

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