Local Excision in Downstaged Rectal Cancer
GRECCAR 2
Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
2 other identifiers
interventional
148
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2007
Longer than P75 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 29, 2007
CompletedStudy Start
First participant enrolled
March 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2018
CompletedMarch 14, 2018
March 1, 2018
7.7 years
January 26, 2007
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 months
Secondary Outcomes (3)
Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect
24 months
5-year survival.
5 years
Quality of life (QLQ C30 - CR38)
at 0, 4, 8 and 12 months
Study Arms (2)
1
EXPERIMENTALNew surgical option in good responders after neoadjuvant treatment for low rectal cancer
2
ACTIVE COMPARATORStandard surgery
Interventions
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bordeauxlead
- Sanoficollaborator
- Roche Pharma AGcollaborator
Study Sites (40)
Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet
Agen, 47000, France
Polyclinique Sainte marguerite
Auxerre, 89000, France
Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming
Besançon, 25030, France
Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron
Bordeaux, 33000, France
Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet
Bordeaux, 33075, France
Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne
Bordeaux, 33076, France
Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle
Boulogne-Billancourt, 92100, France
Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt
Clermont-Ferrand, 63000, France
Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert
Clermont-Ferrand, 63011, France
Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc
Clichy, 92110, France
Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer
La Rochelle, 17000, France
Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne
La Tronche, 38700, France
Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale
Lille, 59020, France
Service de Chirurgie Générale - Hôpitaux Civils de Lyon
Lyon, 69317, France
Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec
Lyon, 69373, France
Institut Paoli Calmette
Marseille, 13009, France
Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre
Marseille, 13385, France
Département de Chirurgie Oncologique - CRLC Val d'Aurelle
Montpellier, 34298, France
CHU Nantes
Nantes, 44000, France
Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose
Nice, 06189, France
Service de Chirurgie Générale - Hôpital Archet II
Nice, 06202, France
CHU Nîmes
Nîmes, 30029, France
Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré
Paris, 75010, France
Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux
Paris, 75010, France
Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron
Paris, 75010, France
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine
Paris, 75012, France
Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine
Paris, 75970, France
Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet
Pierre-Bénite, 69495, France
Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux
Rennes, 35033, France
Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque
Rennes, 35042, France
Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont
Rouen, 76031, France
Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens
Rouen, 76038, France
Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod
Saint-Herblain, 44805, France
Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot
Sainte-Foy-lès-Lyon, 69110, France
Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital
Strasbourg, 67065, France
Service de Chirurgie Digestive - Hôpital Hautepierre
Strasbourg, 67200, France
Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre
Toulouse, 31052, France
Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac
Toulouse, 31059, France
Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne
Vandœuvre-lès-Nancy, 54511, France
Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne
Vandœuvre-lès-Nancy, 54511, France
Related Publications (3)
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.
PMID: 34097005DERIVEDRullier 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.
PMID: 32043980DERIVEDRullier 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.
PMID: 28601342DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric RULLIER, Pr.
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2007
First Posted
January 29, 2007
Study Start
March 5, 2007
Primary Completion
December 1, 2014
Study Completion
February 8, 2018
Last Updated
March 14, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share