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Local Excision in Downstaged Rectal Cancer (GRECCAR 2)

Primary Purpose

Rectal Neoplasms

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
local rectal excision
total mesorectal excision
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rectal Neoplasms focused on measuring Rectal cancer surgery, Neoadjuvant radiochemotherapy, Randomized clinical trial, Multicenter study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet
  • Polyclinique Sainte marguerite
  • Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming
  • Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron
  • Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet
  • Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne
  • Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle
  • Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt
  • Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert
  • Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc
  • Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer
  • Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne
  • Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale
  • Service de Chirurgie Générale - Hôpitaux Civils de Lyon
  • Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec
  • Institut Paoli Calmette
  • Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre
  • Département de Chirurgie Oncologique - CRLC Val d'Aurelle
  • CHU Nantes
  • Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose
  • Service de Chirurgie Générale - Hôpital Archet II
  • CHU Nîmes
  • Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré
  • Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux
  • Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron
  • Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine
  • Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine
  • Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet
  • Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux
  • Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque
  • Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont
  • Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens
  • Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod
  • Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot
  • Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital
  • Service de Chirurgie Digestive - Hôpital Hautepierre
  • Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre
  • Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac
  • Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne
  • Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

New surgical option in good responders after neoadjuvant treatment for low rectal cancer

Standard surgery

Outcomes

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

Secondary Outcome Measures

Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect
5-year survival.
Quality of life (QLQ C30 - CR38)

Full Information

First Posted
January 26, 2007
Last Updated
March 12, 2018
Sponsor
University Hospital, Bordeaux
Collaborators
Sanofi, Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00427375
Brief Title
Local Excision in Downstaged Rectal Cancer
Acronym
GRECCAR 2
Official Title
Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 5, 2007 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Sanofi, Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Rectal cancer surgery, Neoadjuvant radiochemotherapy, Randomized clinical trial, Multicenter study

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard surgery
Intervention Type
Procedure
Intervention Name(s)
local rectal excision
Intervention Description
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
Intervention Type
Procedure
Intervention Name(s)
total mesorectal excision
Intervention Description
standard surgery
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect
Time Frame
24 months
Title
5-year survival.
Time Frame
5 years
Title
Quality of life (QLQ C30 - CR38)
Time Frame
at 0, 4, 8 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric RULLIER, Pr.
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet
City
Agen
ZIP/Postal Code
47000
Country
France
Facility Name
Polyclinique Sainte marguerite
City
Auxerre
ZIP/Postal Code
89000
Country
France
Facility Name
Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Service de Chirurgie Générale - Hôpitaux Civils de Lyon
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Département de Chirurgie Oncologique - CRLC Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Service de Chirurgie Générale - Hôpital Archet II
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
CHU Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot
City
Sainte Foy les Lyon
ZIP/Postal Code
69110
Country
France
Facility Name
Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34097005
Citation
Teste B, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sielezneff I, Prudhomme M, Marchal F, Dubois A, Capdepont M, Denost Q, Rullier E. Early and late morbidity of local excision after chemoradiotherapy for rectal cancer. BJS Open. 2021 May 7;5(3):zrab043. doi: 10.1093/bjsopen/zrab043.
Results Reference
derived
PubMed Identifier
32043980
Citation
Rullier E, Vendrely V, Asselineau J, Rouanet P, Tuech JJ, Valverde A, de Chaisemartin C, Rivoire M, Trilling B, Jafari M, Portier G, Meunier B, Sieleznieff I, Bertrand M, Marchal F, Dubois A, Pocard M, Rullier A, Smith D, Frulio N, Frison E, Denost Q. Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial. Lancet Gastroenterol Hepatol. 2020 May;5(5):465-474. doi: 10.1016/S2468-1253(19)30410-8. Epub 2020 Feb 7.
Results Reference
derived
PubMed Identifier
28601342
Citation
Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.
Results Reference
derived

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Local Excision in Downstaged Rectal Cancer

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