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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eric RULLIER, Pr. | (33) 5 56 79 58 10 | eric.rullier@chu-bordeaux.fr |
| 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 | |
| Principal Investigator: | Eric RULLIER, Pr. | CHU Bordeaux |
| Study Chair: | Genevieve CHENE, Pr. | University Hospital, Bordeaux |
More Information
| 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 |
|
Rectal cancer surgery Neoadjuvant radiochemotherapy Randomized clinical trial Multicenter study |
|
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |