NCT04749108RecruitingPhase 2/3
Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma
Multicentric Phase II-III Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma After a Favorable Response to Induction Chemotherapy
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response. The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders. "Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 1075 (estimated)
- First submitted
- 5 Feb 2021
- Start date
- 26 Nov 2021
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Diseases
- Colorectal cancer
- NCT number
- NCT04749108
- EudraCT number
- 2021-000414-41
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 1075
- From 26 Nov 2021 to the primary completion date, 30 Sept 2029
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Written consent,
- Patient who receive Folfirinox,
- Patient aged over 18 years old,
- World Health Organization (WHO) performance status ≥ 1,
- Histologically confirmed diagnosis of adenocarcinoma of the rectum,
- Distal part of the tumor from 1 to 12 cm from the upper part of the levator ani (dynamic rectal examination),
- No unequivocal evidence on CT-Scan of established metastatic disease,
- MRI evaluation of the locally advanced tumor before neoadjuvant chemotherapy:
- Predictive CRM \< 2 mm
- Or T3c-d (extending ≥ 5 mm beyond the muscularis propria) with extra mural venous invasion (EMVI)
- Or T4a-b (except bone and sphincteric invasion).
- NON INCLUSION CRITERIA FOR SCREENING
- Non measurable rectal tumor or not assessed by MRI before inclusion,
- 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).
- 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),
- 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 \[Ta (non invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)\],
- 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.
- WHO performance status 0-1,
- Patient with tumoral regression ≥ 60% and CRM ≥ 1mm,
- No unequivocal evidence on CT-Scan of established metastatic disease,
- General condition considered suitable for radical pelvic surgery and a systemic therapy with Capecitabine
- 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),
- 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),
- 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,
- No evidence of chronic or acute ischemic heart disease,
- Willing to participate to the study, and able to give informed consent and to comply with the treatment and follow-up schedules,
- Affiliation to the French Social Security System.
- NON-INCLUSION CRITERIA FOR EXPERIMENTAL TREATMENT
- Patient with a history of pelvic radiotherapy,
- Contraindication to chemotherapy and/or radiotherapy,
- Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL),
- Any infection that could jeopardize treatment administration,
- 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),
- History of inflammatory bowel disease,
- Patients with a history of pulmonary fibrosis or interstitial pneumonia,
- 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,
- Known hypersensitivity to Capecitabine drug, study drug classes, or any constituent of the products,
- Patient who received live attenuated vaccine within 10 days of inclusion,
- 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,
- Patient treated with an investigational drug within the last 30 days,
- Patient under curatorship or guardianship or safeguard justice,
- Inability to submit to medical monitoring of the trial for geographical, social or psychological reasons.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| CH Annecy Coordinator of this site? Confirm its status | Annecy | France | Not yet recruiting |
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Bordeaux Colorectal Institute Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| Chu Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Hopital Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Recruiting |
| CHU Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Oscart Lambret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU de Lyon Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| CAC Léon Bérard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hôpital la Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hôpital Européen de Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hopital Nord de Marseille Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Insitut Régional du Cancer de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Centre Alexis Vautrin Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Diaconesses Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Saint-Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CH Pau Coordinator of this site? Confirm its status | Pau | France | Recruiting |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Institut de Cancérologie de l'Ouest Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHU de Nancy Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.