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New hope for rectal cancer: extra chemo may save the rectum

NCT ID NCT02514278

Disease control Sponsor: University Hospital, Bordeaux 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether adding two months of Folfirinox chemotherapy before standard radiation and chemo could help more patients with early-stage rectal cancer avoid major surgery. 218 adults with small, low-lying tumors were enrolled. The goal was to see if more patients could keep their rectum and have no stoma one year after treatment.

What this could mean

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

Active substance
Folfirinox chemotherapy (oxaliplatin, irinotecan, folinic acid, 5FU) and capecitabine
What this could lead to
If it works, this could allow more people with rectal cancer to keep their rectum and avoid a permanent stoma, improving quality of life.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all patients. Adding chemotherapy also increases side effects like nerve damage and digestive issues.

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

218 people

The number who actually took part.

Started

Jan 2016

Finished

Jun 2024

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: * Rectal adenocarcinoma * cT2T3 * cN0-1 (≤ 3 positive lymph nodes or size ≤8mm) * Tumour size ≤4 cm * Location ≤10 cm from the anal verge * No distant metastasis * Patient ≥18 years * ECOG ≤2 * Effective contraception during the study * Patient and doctor have signed informed consent Exclusion Criteria: * T1 or T4 * Tumour size \>4cm * N2 (\>3 positive lymph nodes or size \>8mm) * Tumour \> 10 cm from the anal verge * Distant metastasis * Chronic intestinal inflammation and/or bowel obstruction * Contra indication for chemotherapy and/or radiotherapy * Previous pelvic radiotherapy or chemotherapy * Severe renal, hepatic insufficiency (serum creatinine\<30ml/min) * Peripheral neuropathy \> grade 1 * Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL) * Concomitant treatment with millepertuis, yellow fever vaccine, phenytoin or sorivudine (or chemically equivalent) * Pregnant or breast-feeding woman. * Persons deprived of liberty or under guardianship * Impossibility for compliance to follow-up

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Rectal cancer

Contacts and locations

Locations

  • Département de chirurgie digestive, Institut Gustave Roussy

    Villejuif, France

  • GH Paris Saint Joseph

    Paris, France

  • Service d'Oncologie et Radiothérapie, Centre Azuréen de Cancérologie

    Mougins, France

  • Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre - APHP

    Paris, France

  • Service de Chirurgie Digestive, CHU Amiens Picardie

    Amiens, France

  • Service de Chirurgie Digestive, CHU Carémeau - Nîmes

    Nîmes, France

  • Service de Chirurgie Digestive, CHU Estaing - CHRU Clermont Ferrand

    Clermont-Ferrand, France

  • Service de Chirurgie Digestive, CHU de Besançon

    Besançon, France

  • Service de Chirurgie Digestive, CHU de la Timone - Marseille

    Marseille, France

  • Service de Chirurgie Digestive, Centre Georges François Leclerc - Dijon

    Dijon, France

  • Service de Chirurgie Digestive, Centre Léon Bérard - Lyon

    Lyon, France

  • Service de Chirurgie Digestive, Centre Oscar Lambret - Lille

    Lille, France

  • Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble

    La Tronche, France

  • Service de Chirurgie Digestive, Hôpital Beaujon - APHP

    Clichy, France

  • Service de Chirurgie Digestive, Hôpital Charles Nicolle - CHU de Rouen

    Rouen, France

  • Service de Chirurgie Digestive, Hôpital Haut-Lévêque - CHU de Bordeaux

    Bordeaux, France

  • Service de Chirurgie Digestive, Hôpital Lyon Sud - CHU Lyon

    Lyon, France

  • Service de Chirurgie Digestive, Hôpital Pontchaillou - CHU Rennes

    Rennes, France

  • Service de Chirurgie Digestive, Hôpital Purpan - CHU de Toulouse

    Toulouse, France

  • Service de Chirurgie Digestive, Hôpital Saint-Antoine - APHP

    Paris, France

  • Service de Chirurgie Digestive, Hôpital Saint-Louis - APHP Paris

    Paris, France

  • Service de Chirurgie Digestive, Hôpital les Diaconnesses

    Paris, France

  • Service de Chirurgie Digestive, Hôtel Dieu - CHU de Nantes

    Nantes, France

  • Service de Chirurgie Digestive, Institut Bergonié

    Bordeaux, France

  • Service de Chirurgie Digestive, Institut Paoli Calmette - Marseille

    Marseille, France

  • Service de Chirurgie Digestive, Institut du Cancer de Montpellier

    Montpellier, France

  • Service de Chirurgie Digestive,Institut de Cancérologie de Lorraine

    Nancy, France

  • Service de Chirurgie Digestives, Hôpital Européen de Marseille

    Marseille, France

  • Service de chirurgie digestive, CHRU de Nancy -Hôpital de Brabois

    Vandœuvre-lès-Nancy, France

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