Local Excision in Downstaged Rectal Cancer (GRECCAR 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sanofi
Roche Pharma AG
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00427375
First received: January 26, 2007
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Rectal Neoplasms
Procedure: local rectal excision
Procedure: total mesorectal excision
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 5-year survival. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of life (QLQ C30 - CR38) [ Time Frame: at 0, 4, 8 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: March 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427375

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

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00427375     History of Changes
Other Study ID Numbers: CHUBX 2006/03, 2005-025
Study First Received: January 26, 2007
Last Updated: May 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Rectal cancer surgery
Neoadjuvant radiochemotherapy
Randomized clinical trial
Multicenter study

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014