Study Results
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Basic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2007-03-05
2018-02-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
local rectal excision
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
2
Standard surgery
total mesorectal excision
standard surgery
Interventions
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local rectal excision
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
total mesorectal excision
standard surgery
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Roche Pharma AG
INDUSTRY
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Eric RULLIER, Pr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet
Agen, , France
Polyclinique Sainte marguerite
Auxerre, , France
Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming
Besançon, , France
Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron
Bordeaux, , France
Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet
Bordeaux, , France
Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne
Bordeaux, , France
Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle
Boulogne-Billancourt, , France
Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt
Clermont-Ferrand, , France
Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert
Clermont-Ferrand, , France
Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc
Clichy, , France
Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer
La Rochelle, , France
Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne
La Tronche, , France
Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale
Lille, , France
Service de Chirurgie Générale - Hôpitaux Civils de Lyon
Lyon, , France
Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec
Lyon, , France
Institut Paoli Calmette
Marseille, , France
Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre
Marseille, , France
Département de Chirurgie Oncologique - CRLC Val d'Aurelle
Montpellier, , France
CHU Nantes
Nantes, , France
Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose
Nice, , France
Service de Chirurgie Générale - Hôpital Archet II
Nice, , France
CHU Nîmes
Nîmes, , France
Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré
Paris, , France
Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux
Paris, , France
Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron
Paris, , France
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine
Paris, , France
Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine
Paris, , France
Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet
Pierre-Bénite, , France
Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux
Rennes, , France
Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque
Rennes, , France
Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont
Rouen, , France
Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens
Rouen, , France
Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod
Saint-Herblain, , France
Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot
Sainte-Foy-lès-Lyon, , France
Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital
Strasbourg, , France
Service de Chirurgie Digestive - Hôpital Hautepierre
Strasbourg, , France
Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre
Toulouse, , France
Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac
Toulouse, , France
Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne
Vandœuvre-lès-Nancy, , France
Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne
Vandœuvre-lès-Nancy, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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2005-025
Identifier Type: -
Identifier Source: secondary_id
CHUBX 2006/03
Identifier Type: -
Identifier Source: org_study_id
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