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New radiation approach may help rectal cancer patients avoid surgery

NCT ID NCT02505750

Disease control Sponsor: Centre Antoine Lacassagne 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a special type of internal radiation (contact X-ray brachytherapy) given after standard chemoradiation can help more people with early rectal cancer keep their rectum, compared to standard external beam radiation. About 148 adults with small, early-stage rectal tumors will be randomly assigned to one of the two boost methods. The goal is to see if the internal radiation increases the chance of organ preservation at 3 years without the need for major surgery.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

148 people

The number who actually took part.

Started

Jun 2015

Expected to finish

Jun 2030

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. Adenocarcinoma of the rectum classified clinically T2, T3a, T3b (penetration in the mesorectal fat between 1 to 5 mm) by TNM classification (Tumour Node Metastase), \< 5 cm largest diameter, \< half rectal circumference (by MRI staging), N0-N1 (any node \< 8 mm diameter on MRI), M0 2. Operable patient 3. Tumour accessible to endocavitary contact X-Ray Brachytherapy with a distance from the lower tumour border to the anal verge ≤ 10cm 4. 18 years or above 5. No comorbidity preventing treatment 6. Adequate birth control 7. Patient having read the information note and having signed the informed consent 8. Health care insurance available 9. Follow-up possible Exclusion Criteria: 1. Inoperable patient 2. T1, T3cd, T4, T≥ 5cm, T≥ ½ circumference 3. Patient N2 at diagnosis or N1 with any node \> 8 mm diameter 4. Patient presenting metastasis at diagnosis 5. Previous pelvic irradiation 6. Tumour with extramural vascular invasion 7. Simultaneous progressive cancer 8. Tumour invading external anal sphincter and within 1 mm, and the levator muscle 9. Patient unable to receive CXB or CRT 10. Tumour with poor differentiation (G3) 11. People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside state to express their consent, pregnant or breastfeeding women 12. Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy 13. Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol 14. Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment

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Conditions

The condition(s) this trial relates to.

rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Rectal neoplasms

Contacts and locations

Locations

  • CHRU Besançon

    Besançon, Bourgogne-Franche-Comté, 25030, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Jean Godinot

    Reims, Champagne-Ardenne, 51726, France

  • Centre Léon Bérard

    Lyon, 69008, France

  • Centre d'oncologie et de radiothérapie Mâcon

    Mâcon, 71000, France

  • Centre de radiothérapie Bayard

    Villeurbanne, 69100, France

  • Christie Hospital

    Manchester, M204BX, United Kingdom

  • Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L9 7BA, United Kingdom

  • Clinique Charcot

    Sainte-Foy-lès-Lyon, 69110, France

  • Clinique de la Sauvegarde

    Lyon, Auvergne-Rhône-Alpes, 69009, France

  • Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495, France

  • Hôpital de la Croix Rouge Française - Centre de Radiothérapie St Louis

    Toulon, 83100, France

  • Hôpitaux Universitaires de Genève

    Geneva, CG-1211, Switzerland

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42270, France

  • Royal Surrey County Hospital

    Guildford, GU2 7XX, United Kingdom

  • Spire Hull and East Riding Hospital

    Hull, HU10 7AZ, United Kingdom

  • University Hospital

    Nottingham, NG5 8RX, United Kingdom

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Other studies related to the condition(s) this trial covers.