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MRI-Guided therapy could spare rectal cancer patients from unnecessary surgery

NCT ID NCT04749108

Disease control Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This study is for people with locally advanced rectal cancer. It tests whether using MRI scans early after chemotherapy can help doctors choose the best next step: surgery or more chemo with radiation. The goal is to improve cancer control and reduce side effects. About 1,075 participants will take part.

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 1,075 people

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

Started

Nov 2021

Expected to finish

Sep 2031

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 FOR SCREENING 1. Written consent, 2. Patient who receive Folfirinox, 3. Patient aged over 18 years old, 4. World Health Organization (WHO) performance status ≥ 1, 5. Histologically confirmed diagnosis of adenocarcinoma of the rectum, 6. Distal part of the tumor from 1 to 12 cm from the upper part of the levator ani (dynamic rectal examination), 7. No unequivocal evidence on CT-Scan of established metastatic disease, 8. MRI evaluation of the locally advanced tumor before neoadjuvant chemotherapy: 1. Predictive CRM \< 2 mm 2. Or T3c-d (extending ≥ 5 mm beyond the muscularis propria) with extra mural venous invasion (EMVI) 3. Or T4a-b (except bone and sphincteric invasion). NON INCLUSION CRITERIA FOR SCREENING 1. Non measurable rectal tumor or not assessed by MRI before inclusion, 2. Ultra-low rectal tumor at diagnosis which imposes radiotherapy administration (inferior tumor pole less than 1 cm from the upper part of the levator ani). 3. Active cardiac disease including any of the following: a. Congestive heart failure ≥ New York Heart Association (NYHA) class 2 (appendix 4), b. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), c. Myocardial infarction less than 6 months before first dose of treatment, d. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), 4. Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)\], 5. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before start of treatment. INCLUSION CRITERIA FOR EXPERIMENTAL TREATMENT 1. WHO performance status 0-1, 2. Patient with tumoral regression ≥ 60% and CRM ≥ 1mm, 3. No unequivocal evidence on CT-Scan of established metastatic disease, 4. General condition considered suitable for radical pelvic surgery and a systemic therapy with Capecitabine 5. Adequate hematologic, hepatic, renal and ionogram function assessed within 7 days prior to study treatment a. Platelet count ≥ 100,000/mm3; Hemoglobin (Hb) ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1,500/ mm3 b. Total bilirubin ≤ 1.5 x Upper Limit Normal (ULN), Alkaline phosphatases ≤ 3 x ULN and ASpartate aminoTransferase (AST) and ALanine aminoTransferase (ALT) ≤ 3 x ULN, c. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min according to Modification of Diet in Renal Disease (MDRD), 6. For women of reproductive potential, negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test obtained within 7 days before the start of study treatment. Women not of reproductive potential are female patients who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), 7. For women of childbearing potential and men, agreement to use an adequate contraception for the duration of study participation and up to 6 months following completion of therapy. Females of childbearing potential who are sexually active with a non-sterilized male partner must use 2 methods, of effective contraception. The investigator or a designated associate is requested to advise the patient on how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care, 8. No evidence of chronic or acute ischemic heart disease, 9. Willing to participate to the study, and able to give informed consent and to comply with the treatment and follow-up schedules, 10. Affiliation to the French Social Security System. NON-INCLUSION CRITERIA FOR EXPERIMENTAL TREATMENT 1. Patient with a history of pelvic radiotherapy, 2. Contraindication to chemotherapy and/or radiotherapy, 3. Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL), 4. Any infection that could jeopardize treatment administration, 5. Any other serious concomitant disease or disorder that may interfere with the patient's participation in the study and safety during the study (e.g., severe liver, heart, kidney, lung, metabolic, or psychiatric disorders), 6. History of inflammatory bowel disease, 7. Patients with a history of pulmonary fibrosis or interstitial pneumonia, 8. Patients using antivitamin K (Coumadin etc…) but it's possible to substitute the antivitamin K treatment with low molecular weight heparins (LMWHs) before starting chemotherapy, 9. Known hypersensitivity to Capecitabine drug, study drug classes, or any constituent of the products, 10. Patient who received live attenuated vaccine within 10 days of inclusion, 11. Pregnant or breastfeeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (serum β-hCG) documented 72 hours prior to inclusion, 12. Patient treated with an investigational drug within the last 30 days, 13. Patient under curatorship or guardianship or safeguard justice, 14. Inability to submit to medical monitoring of the trial for geographical, social or psychological reasons.

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Conditions

The condition(s) this trial relates to.

cancer rectal carcinoma rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Locally advanced malignant neoplasm Rectal carcinoma

How to take part

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

  1. The places running it

    30 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Bordeaux Colorectal Institute

    RECRUITING

    Bordeaux, 33300, France

  • CAC Léon Bérard

    RECRUITING

    Lyon, France

  • CH Annecy

    NOT_YET_RECRUITING

    Annecy, Savoie, 74330, France

  • CH PAU

    RECRUITING

    Pau, Pyrénées-atlantiques, 64000, France

  • CHU Amiens

    RECRUITING

    Amiens, Picardie, 80054, France

  • CHU Besançon

    RECRUITING

    Besançon, Doubs, 25030, France

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, Puy De Dôme, 63000, France

  • CHU Rouen

    RECRUITING

    Rouen, Seine-Maritime, 76031, France

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, Gironde, 33600, France

  • CHU de Lyon

    RECRUITING

    Lyon, Rhône, 69310, France

  • CHU de Nancy

    RECRUITING

    Vandœuvre-lès-Nancy, Lorraine, 54511, France

  • CHU de Nîmes

    RECRUITING

    Nîmes, 30029, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Centre Alexis Vautrin

    RECRUITING

    Nancy, Meurthe Et Moselle, 54519, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, France

  • Centre Georges-François Leclerc

    NOT_YET_RECRUITING

    Dijon, 21079, France

  • Centre Oscart Lambret

    RECRUITING

    Lille, Nord, 59000, France

  • Chu Grenoble

    RECRUITING

    Grenoble, France

  • Chu Lille

    RECRUITING

    Lille, 59037, France

  • Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, Val De Marne, 94270, France

  • Hôpital Diaconesses

    RECRUITING

    Paris, 75020, France

  • Hôpital Européen Georges-Pompidou

    RECRUITING

    Paris, 75015, France

  • Hôpital Européen de MARSEILLE

    RECRUITING

    Marseille, Bouches-du-rhône, 13003, France

  • Hôpital La Timone

    RECRUITING

    Marseille, 13005, France

  • Hôpital Nord de Marseille

    NOT_YET_RECRUITING

    Marseille, Bouches Du Rhône, 13015, France

  • Hôpital Saint-Antoine

    RECRUITING

    Paris, 75012, France

  • Hôpital Saint-Louis

    RECRUITING

    Paris, 75010, France

  • Insitut Régional du Cancer de Montpellier

    RECRUITING

    Montpellier, Hérault, 34298, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, Bouches Du Rhône, 13009, France

  • Institut de Cancérologie de l'Ouest

    RECRUITING

    Saint-Herblain, 44800, France

More trials for these conditions

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