Local Excision in Downstaged Rectal Cancer (GRECCAR 2)

March 12, 2018 updated by: University Hospital, Bordeaux

Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rectal excision is the standard surgical treatment of rectal cancer. The risk of mortality and major short and long term morbidity induced by rectal excision justifies new treatments. Local excision is a conservative alternative approach associated with low mortality and morbidity. The purpose of this prospective randomised multicenter study is to compare local vs rectal excision in good responders after radiochemotherapy for low rectal cancer.

Patients with T2T3 low rectal cancer, less than 8 cm from the anal verge, size =< 4 cm, received neoadjuvant treatment, included radiotherapy between 45-55Gy in 5 weeks with concomitant chemotherapy consist of at least, one fluoropyrimidine.

Good clinical responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. In case of not confirmed pathological response following local excision, complementary rectal excision is required.

Bad responders (residual tumour > 2cm) are treated by primary rectal excision. Follow-up includes digital rectal examination, CT-scan and endorectal ultrasound (if local excision) every 4 months for 2 years, then every 6 months for 3 years.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47000
        • Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet
      • Auxerre, France, 89000
        • Polyclinique Sainte marguerite
      • Besançon, France, 25030
        • Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming
      • Bordeaux, France, 33000
        • Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron
      • Bordeaux, France, 33075
        • Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet
      • Bordeaux, France, 33076
        • Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne
      • Boulogne Billancourt, France, 92100
        • Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle
      • Clermont-Ferrand, France, 63000
        • Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt
      • Clermont-Ferrand, France, 63011
        • Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert
      • Clichy, France, 92110
        • Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc
      • La Rochelle, France, 17000
        • Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer
      • La Tronche, France, 38700
        • Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne
      • Lille, France, 59020
        • Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale
      • Lyon, France, 69317
        • Service de Chirurgie Générale - Hôpitaux Civils de Lyon
      • Lyon, France, 69373
        • Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec
      • Marseille, France, 13009
        • Institut Paoli Calmette
      • Marseille, France, 13385
        • Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre
      • Montpellier, France, 34298
        • Département de Chirurgie Oncologique - CRLC Val d'Aurelle
      • Nantes, France, 44000
        • CHU Nantes
      • Nice, France, 06189
        • Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose
      • Nice, France, 06202
        • Service de Chirurgie Générale - Hôpital Archet II
      • Nîmes, France, 30029
        • Chu Nimes
      • Paris, France, 75010
        • Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré
      • Paris, France, 75010
        • Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux
      • Paris, France, 75010
        • Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron
      • Paris, France, 75012
        • Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine
      • Paris, France, 75970
        • Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine
      • Pierre Benite, France, 69495
        • Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet
      • Rennes, France, 35033
        • Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux
      • Rennes, France, 35042
        • Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque
      • Rouen, France, 76031
        • Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont
      • Rouen, France, 76038
        • Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens
      • Saint Herblain, France, 44805
        • Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod
      • Sainte Foy les Lyon, France, 69110
        • Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot
      • Strasbourg, France, 67065
        • Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital
      • Strasbourg, France, 67200
        • Service de Chirurgie Digestive - Hôpital Hautepierre
      • Toulouse, France, 31052
        • Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre
      • Toulouse, France, 31059
        • Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac
      • Vandoeuvre les Nancy, France, 54511
        • Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne
      • Vandoeuvre les Nancy, France, 54511
        • Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • T2T3 low adenocarcinoma of the rectum
  • Tumour size =< 4cm
  • Less than 8 cm from the anal verge
  • No metastatic disease
  • Patient is at least 18 years of age
  • ECOG performance status score =< 2
  • Patient and doctor have signed informed consent
  • inclusion criteria : Residual clinical tumour size =< 2cm after radiochemotherapy

Exclusion Criteria:

  • T1, T4 tumour or anal sphincter invasion
  • Metastatic disease (M1)
  • Contra indication for radiotherapy and/or fluoropyrimidine use in chemotherapy
  • History of cancer
  • Symptomatic cardiac or coronary insufficiency
  • Severe renal insufficiency
  • Peripheral neuropathy
  • Patient included in a trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
Procedure: local rectal excision
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
Active Comparator: 2
Standard surgery
Procedure: total mesorectal excision
standard surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect
Time Frame: 24 months
24 months
5-year survival.
Time Frame: 5 years
5 years
Quality of life (QLQ C30 - CR38)
Time Frame: at 0, 4, 8 and 12 months
at 0, 4, 8 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Sanofi
Roche Pharma AG

Investigators

  • Principal Investigator: Eric RULLIER, Pr., CHU Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 8, 2018

Study Registration Dates

First Submitted

January 26, 2007

First Submitted That Met QC Criteria

January 26, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2006/03
  • 2005-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Neoplasms

Clinical Trials on local rectal excision

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe