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Local Excision in Downstaged Rectal Cancer (GRECCAR 2)
This study is currently recruiting participants.
Verified by University Hospital, Bordeaux, July 2009
First Received: January 26, 2007   Last Updated: July 29, 2009   History of Changes
Sponsor: University Hospital, Bordeaux
Collaborators: Sanofi-Synthelabo
Hoffmann-La Roche
Information provided by: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00427375
  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 III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment: 300
Study Start Date: March 2007
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
2: Active Comparator
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

Contacts
Contact: Eric RULLIER, Pr. (33) 5 56 79 58 10 eric.rullier@chu-bordeaux.fr

Locations
France
Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne Recruiting
Bordeaux, France, 33076
Principal Investigator: Serge Evrard            
Sub-Investigator: Hortense Laharie-mineur            
Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt Recruiting
Clermont-Ferrand, France, 63000
Contact: , Pr.            
Principal Investigator: Denis Pezet            
Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert Recruiting
Clermont-Ferrand, France, 63011
Principal Investigator: Pierre Verrelle            
Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne Recruiting
La Tronche, France, 38700
Principal Investigator: Jean-Luc Faucheron            
Sub-Investigator: Jacques Balosso            
Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale Recruiting
Lille, France, 59020
Principal Investigator: Luc Vanseymortier            
Sub-Investigator: Mehrdad Jafari            
Sub-Investigator: Antoine Adenis            
Sub-Investigator: Xavier Mirabel            
Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec Recruiting
Lyon, France, 69373
Principal Investigator: Michel Rivoire            
Sub-Investigator: François Mithieux            
Sub-Investigator: Pierre Meeus            
Sub-Investigator: Isabelle Martel-Laffay            
Sub-Investigator: Chistelle De La Fouchardière            
Sub-Investigator: Françoise Desseigne            
Service de Chirurgie Générale - Hôpitaux Civils de Lyon Recruiting
Lyon, France, 69317
Principal Investigator: Jacques Baulieux            
Sub-Investigator: Jean-Yves Mabrut            
Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot Recruiting
Sainte Foy les Lyon, France, 69110
Principal Investigator: Marc Papillon            
Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet Recruiting
Pierre Benite, France, 69495
Principal Investigator: Pascale Romestaing            
Institut Paoli Calmette Recruiting
Marseille, France, 13009
Principal Investigator: Bernard Lelong            
Sub-Investigator: Laurence Moureau            
Sub-Investigator: Frédéric Viret            
Département de Chirurgie Oncologique - CRLC Val d'Aurelle Recruiting
Montpellier, France, 34298
Principal Investigator: Philippe Rouanet            
Sub-Investigator: Bernard Saint-Aubert            
Sub-Investigator: François Quenet            
Sub-Investigator: Marian Gutowski            
Sub-Investigator: Anne Mourregot            
Sub-Investigator: David Azria            
Sub-Investigator: Carmen Llacer            
Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne Recruiting
Vandoeuvre les Nancy, France, 54511
Principal Investigator: Laurent Bresler            
Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne Not yet recruiting
Vandoeuvre les Nancy, France, 54511
Principal Investigator: Frédéric Marchal            
Sub-Investigator: Didier Peiffert            
Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod Recruiting
Saint Herblain, France, 44805
Principal Investigator: François Dravet            
Sub-Investigator: Jacques Paineau            
Sub-Investigator: Marc André Mahe            
Sub-Investigator: Emmanuel Rio            
Service de Chirurgie Générale - Hôpital Archet II Recruiting
Nice, France, 06202
Principal Investigator: Daniel Benchimol            
Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose Not yet recruiting
Nice, France, 06189
Principal Investigator: Jean-Pierre Gerard            
Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle Recruiting
Boulogne Billancourt, France, 92100
Principal Investigator: Stéphane Benoist            
Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron Recruiting
Paris, France, 75010
Principal Investigator: Henri Mosnier            
Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet Recruiting
Bordeaux, France, 33075
Contact: Eric RULLIER, Pr.     (33) 5 56 79 58 10     eric.rullier@chu-bordeaux.fr    
Sub-Investigator: Christophe Laurent, Dr            
Sub-Investigator: Véronique Vendrely, Dr            
Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc Recruiting
Clichy, France, 92110
Principal Investigator: Yves Panis            
Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré Recruiting
Paris, France, 75010
Principal Investigator: Marc Pocard            
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine Recruiting
Paris, France, 75012
Principal Investigator: Emmanuel Tiret            
Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine Recruiting
Paris, France, 75970
Principal Investigator: Emmanuel Touboul            
Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux Recruiting
Rennes, France, 35033
Principal Investigator: Bernard Meunier            
Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque Not yet recruiting
Rennes, France, 35042
Principal Investigator: Emmanuelle Le Prise            
Sub-Investigator: Jean-Luc Raoul            
Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont Recruiting
Rouen, France, 76031
Principal Investigator: Francis Michot            
Sub-Investigator: Jean-Jacques Tuech            
Sub-Investigator: Pierre Michel            
Sub-Investigator: Frédéric Di Fiore            
Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens Not yet recruiting
Rouen, France, 76038
Principal Investigator: Hadji Hamidou            
Service de Chirurgie Digestive - Hôpital Hautepierre Recruiting
Strasbourg, France, 67200
Principal Investigator: Jean-Claude Ollier            
Sub-Investigator: Cécile brigand            
Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital Not yet recruiting
Strasbourg, France, 67065
Principal Investigator: Catherine Scumacher            
Sub-Investigator: Christian Borel            
Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac Not yet recruiting
Toulouse, France, 31059
Principal Investigator: Guillaume Portier            
Sub-Investigator: Rosine Guibnaud            
Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre Not yet recruiting
Toulouse, France, 31052
Principal Investigator: Michel Rives            
Sub-Investigator: Rosine Guibnaud            
Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre Not yet recruiting
Marseille, France, 13385
Principal Investigator: Bernard Antoine Sastre            
Sub-Investigator: Igor Sielezneff            
Sub-Investigator: jean-François Seitz            
Sub-Investigator: Laetitia Dahan            
Sub-Investigator: Muriel Duluc            
Sub-Investigator: Pauline Ries-Guye            
Sub-Investigator: Emmanuelle Ressiot-Geromali Santandrea            
Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming Not yet recruiting
Besançon, France, 25030
Principal Investigator: Georges Mantion            
Sub-Investigator: Jean-François Bosset            
Sub-Investigator: Joëlle Buffet-Miny            
Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet Not yet recruiting
Agen, France, 47000
Principal Investigator: Christian Cronier            
Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron Recruiting
Bordeaux, France, 33000
Principal Investigator: Hortense Laharie            
Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer Not yet recruiting
La Rochelle, France, 17000
Principal Investigator: Denis Langlois            
Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux Recruiting
Paris, France, 75010
Principal Investigator: Christophe Hennequin            
Sponsors and Collaborators
University Hospital, Bordeaux
Sanofi-Synthelabo
Hoffmann-La Roche
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 ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers: CHUBX 2006/03, 2005-025
Study First Received: January 26, 2007
Last Updated: July 29, 2009
ClinicalTrials.gov Identifier: NCT00427375     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

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

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

ClinicalTrials.gov processed this record on November 30, 2009