Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID04749108

Multicentric Phase II-III Study Evaluating Personalized Treatment of Locally Advanced Rectal Carcinoma After Favorable Response to Induction Chemotherapy

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-02-05

1075

Participants Needed

30

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying locally advanced rectal carcinoma, a type of rectal cancer that poses challenges in controlling the disease and managing treatment side effects. Surgery alone cures only about half the patients, while radiochemotherapy improves local control but still leaves a 30% risk of metastasis and increased postoperative issues. This trial aims to personalize treatment based on the tumor's early response to induction chemotherapy, measured by MRI volume changes, to better tailor therapy for good and poor responders. The trial includes an induction chemotherapy phase using a modified FOLFIRINOX regimen delivered every 15 days for six cycles. Early tumor response is evaluated by MRI two weeks after chemotherapy completion. Patients classified as "very good" responders will be randomly assigned to one of two study groups: one undergoing immediate proctectomy surgery within 4 to 6 weeks, and the other receiving radiochemotherapy with capecitabine combined with radiotherapy over 5 weeks followed by surgery after 7 weeks. The proctectomy can be performed via laparoscopic or conventional surgery. Participants will undergo assessments including MRI scans, pathology analysis after surgery, and quality of life questionnaires over one year. Researchers will monitor surgical outcomes, disease-free survival at 3 years, local and distant recurrence rates, adverse events, and functional outcomes such as urinary and sexual function. The study plans to recruit approximately 430 patients to evaluate both surgical quality and long-term effectiveness of this personalized treatment approach.

CONDITIONS

Brief Title

Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written consent to participate in the study
  • Patient who has received FOLFIRINOX induction chemotherapy
  • Age 18 years or older
  • World Health Organization (WHO) performance status 0 or 1
  • Histologically confirmed adenocarcinoma of the rectum
  • Tumor located 1 to 12 cm from the upper part of the levator ani muscle
  • No clear evidence of metastatic disease on CT scan
  • MRI shows predictive circumferential resection margin less than 2 mm, or T3c-d tumor with extra mural venous invasion, or T4a-b tumor (excluding bone and sphincter invasion)
  • Suitable general condition for radical pelvic surgery and systemic therapy with capecitabine
  • Adequate blood counts and liver, kidney, and electrolyte function within 7 days prior to treatment
  • For women of reproductive potential, negative pregnancy test within 7 days before treatment
  • Agreement to use effective contraception during study and for 6 months after
  • Affiliation to the French Social Security System
  • Willing and able to comply with treatment and follow-up schedules
Not Eligible

You will not qualify if you...

  • Non-measurable rectal tumor or tumor not assessed by MRI before inclusion
  • Ultra-low rectal tumor requiring mandatory radiotherapy
  • Active cardiac disease including congestive heart failure NYHA class 2 or higher, unstable angina, recent myocardial infarction within 6 months, or arrhythmias requiring anti-arrhythmic therapy
  • Previous or concurrent cancer within 5 years except certain treated cancers
  • Thrombotic or embolic events within 6 months prior to treatment
  • History of pelvic radiotherapy
  • Contraindication to chemotherapy or radiotherapy
  • Complete or partial Dihydropyrimidine dehydrogenase deficiency
  • Infection that could interfere with treatment
  • Serious concomitant diseases interfering with participation or safety
  • History of inflammatory bowel disease
  • History of pulmonary fibrosis or interstitial pneumonia
  • Use of antivitamin K drugs unless replaced by low molecular weight heparins before chemotherapy
  • Known hypersensitivity to capecitabine or study drugs
  • Live attenuated vaccine within 10 days before inclusion
  • Pregnant or breastfeeding women
  • Participation in another investigational drug study within last 30 days
  • Under legal guardianship or unable to comply with study monitoring due to social, psychological, or geographic reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Induction Chemotherapy

Duration - Approximately 3 months

Participants receive induction chemotherapy with a modified FOLFIRINOX regimen consisting of 6 cycles administered every 15 days to treat locally advanced rectal carcinoma.

6 treatment visits every 15 days

Early Tumor Response Evaluation

Duration - 1 day

Two weeks after completion of induction chemotherapy, participants undergo MRI volumetry to evaluate early tumor response.

1 visit (in-person)

Treatment Assignment and Intervention

Duration - Up to 12 weeks depending on assigned treatment

Based on tumor response, participants are randomized to one of two treatment options: immediate rectal surgery or chemoradiotherapy followed by surgery.

1 to 6 visits depending on treatment arm

Immediate Rectal Surgery

Duration - 1 day for surgery plus recovery period

Participants classified as very good responders undergo radical proctectomy with total mesorectal excision within 4 to 6 weeks after randomization.

1 surgical visit plus follow-up visits

Chemoradiotherapy and Surgery

Duration - Approximately 12 weeks including radiotherapy and surgery

Participants receive radiochemotherapy with oral capecitabine and radiotherapy for 5 weeks, followed by radical proctectomy approximately 7 weeks later.

Weekly visits during radiotherapy and 1 surgical visit plus follow-up

Post-Treatment Follow-up

Duration - Up to 5 years

Participants are monitored for up to 5 years to assess disease-free survival, overall survival, quality of life, and any late effects of treatment.

Periodic visits over 5 years

Trial Site Locations

Total: 30 locations

1

Institut Paoli Calmettes

Marseille, Bouches Du Rhône, France, 13009

Actively Recruiting

2

Hôpital Nord de Marseille

Marseille, Bouches Du Rhône, France, 13015

Not Yet Recruiting

3

Hôpital Européen de MARSEILLE

Marseille, Bouches-du-rhône, France, 13003

Actively Recruiting

4

CHU Besançon

Besançon, Doubs, France, 25030

Actively Recruiting

5

CHU de Bordeaux

Bordeaux, Gironde, France, 33600

Actively Recruiting

6

Insitut Régional du Cancer de Montpellier

Montpellier, Hérault, France, 34298

Actively Recruiting

7

CHU de Nancy

Vandœuvre-lès-Nancy, Lorraine, France, 54511

Actively Recruiting

8

Centre Alexis Vautrin

Nancy, Meurthe Et Moselle, France, 54519

Actively Recruiting

9

Centre Oscart Lambret

Lille, Nord, France, 59000

Actively Recruiting

10

CHU Amiens

Amiens, Picardie, France, 80054

Actively Recruiting

11

CHU Clermont-Ferrand

Clermont-Ferrand, Puy De Dôme, France, 63000

Actively Recruiting

12

CH PAU

Pau, Pyrénées-atlantiques, France, 64000

Actively Recruiting

13

CHU de Lyon

Lyon, Rhône, France, 69310

Actively Recruiting

14

CH Annecy

Annecy, Savoie, France, 74330

Not Yet Recruiting

15

CHU Rouen

Rouen, Seine-Maritime, France, 76031

Actively Recruiting

16

Hôpital Bicêtre

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

Actively Recruiting

17

Bordeaux Colorectal Institute

Bordeaux, France, 33300

Actively Recruiting

18

Centre Georges-François Leclerc

Dijon, France, 21079

Not Yet Recruiting

19

Chu Grenoble

Grenoble, France

Actively Recruiting

20

Chu Lille

Lille, France, 59037

Actively Recruiting

21

CAC Léon Bérard

Lyon, France

Actively Recruiting

22

Hôpital La Timone

Marseille, France, 13005

Actively Recruiting

23

Centre Antoine Lacassagne

Nice, France

Actively Recruiting

24

CHU de Nîmes

Nîmes, France, 30029

Actively Recruiting

25

Hôpital Saint-Louis

Paris, France, 75010

Actively Recruiting

26

Hôpital Saint-Antoine

Paris, France, 75012

Actively Recruiting

27

Hôpital Européen Georges-Pompidou

Paris, France, 75015

Actively Recruiting

28

Hôpital Diaconesses

Paris, France, 75020

Actively Recruiting

29

Institut de Cancérologie de l'Ouest

Saint-Herblain, France, 44800

Actively Recruiting

30

CHU de Toulouse

Toulouse, France, 31059

Actively Recruiting

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Research Team

P

Philippe Rouanet, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years.

Rolf Sauer, Torsten Liersch, Susanne Merkel...

https://pubmed.ncbi.nlm.nih.gov/22529255

Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial.

Claus Rödel, Ullrich Graeven, Rainer Fietkau...

https://pubmed.ncbi.nlm.nih.gov/26189067

Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer.

S T Martin, H M Heneghan, D C Winter

https://pubmed.ncbi.nlm.nih.gov/22362002

Bowel dysfunction after low anterior resection with and without neoadjuvant therapy for rectal cancer: a population-based cross-sectional study.

S Bregendahl, K J Emmertsen, J Lous...

https://pubmed.ncbi.nlm.nih.gov/23581977

Bowel function 14 years after preoperative short-course radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomized trial.

Tina Yen-Ting Chen, Lisette M Wiltink, Remi A Nout...

https://pubmed.ncbi.nlm.nih.gov/25677122

Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer: a pilot trial.

Deborah Schrag, Martin R Weiser, Karyn A Goodman...

https://pubmed.ncbi.nlm.nih.gov/24419115

Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial.

Philippe Rouanet, Eric Rullier, Bernard Lelong...

https://pubmed.ncbi.nlm.nih.gov/28594714

Tumor volume changes assessed by three-dimensional magnetic resonance volumetry in rectal cancer patients after preoperative chemoradiation: the impact of the volume reduction ratio on the prediction of pathologic complete response.

Jeong Hyun Kang, Young Chul Kim, Hyunki Kim...

https://pubmed.ncbi.nlm.nih.gov/19647949