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New combo therapy aims to cut treatment breaks for anal cancer patients

NCT ID NCT02701088

Disease control Sponsor: Centre Francois Baclesse 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This Phase 2 trial tests a new way of delivering radiation therapy (SIB-IMRT) together with standard chemotherapy (5-FU and Mitomycin-C) for people with locally advanced anal cancer. The goal is to see if this approach can improve tumor control and reduce the severe side effects that often force patients to take breaks from treatment. About 71 participants will be followed for up to a year to measure outcomes like tumor response, side effects, 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
5-Fluorouracil and Mitomycin-C (chemotherapy drugs) plus a special type of radiation therapy (SIB-IMRT) that delivers different doses to different areas at the same time.
What this could lead to
If successful, this could offer a more effective and less toxic treatment for locally advanced anal cancer, potentially reducing the need for treatment breaks and improving quality of life.
What could go wrong
This is a Phase 2 trial with only 71 participants, so results may not apply to everyone. The combination may still cause significant side effects, and the long-term benefits are not yet proven.

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

71 people

The number who actually took part.

Started

Dec 2015

Finished

Dec 2025

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: * WHO performance status ≤ 2 * Age \> 18 years * Epidermoid anal canal carcinoma histologically proven, locally advanced with an indication of radiation of pelvic and inguinal nodes concomitantly to chemotherapy * The T corresponds to the larger dimension of tumor at the rectal examination and the N is assessed by imaging pelvic MRI-imaging, CT-scan, optionally PET-CT). Eligible tumors are: T2 more than 4 cm N0-N3, T2-T4 N1-N3 or usN1, T3-T4 N0, M0 according to the 6th edition of the American Joint Committee on cancer staging manual. * Laboratory data obtained ≤ 14 days prior to registration on study, with adequate bone marrow, hepatic and renal function defined as follows: hemoglobinemia, neutrophil, platelet counts, bilirubin and creatinin level * Informed consent form Exclusion Criteria: * Previous invasive cancer within 5 years except basocellular cancer and in situ cervical cancer * Tumors with predominant skin involvement * Presence of metastases * History of pelvic irradiation * Contraindication to radiotherapy or chemotherapy * Known HIV positive patients

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Conditions

The condition(s) this trial relates to.

anal canal cancer anal canal carcinoma

As listed by the trial registrant

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

Locally advanced anal canal cancer

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, France

  • Centre François Baclesse

    Caen, 14076, France

  • Centre Léon Berard

    Lyon, France

  • Centre Paul Strauss

    Strasbourg, France

  • IUCT-Oncopole

    Toulouse, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

  • Institut de Cancérologie de l'Ouest - Centre Paul Papin

    Angers, France

  • Institut de cancérologie de l'Ouest

    Saint-Herblain, 44805, France