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NCT00427375 Clinical Trial

Local Excision in Downstaged Rectal Cancer

Rectal Neoplasms Clinical Trial

— GRECCAR 2  

Official title:
Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00427375
Other study ID # CHUBX 2006/03
Secondary ID 2005-025
Status Completed
Phase Phase 3
First received January 26, 2007
Last updated March 12, 2018
Start date March 5, 2007
Est. completion date February 8, 2018

Study information
Verified date March 2018
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 148
Est. completion date February 8, 2018
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• local rectal excision
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
• total mesorectal excision
standard surgery

Locations
Country Name City State
France 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 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 Radiothérapie - Clinique Tivoli - 220 rue Mandron Bordeaux
France Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle Boulogne Billancourt
France Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert Clermont-Ferrand
France Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt 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 Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec Lyon
France Service de Chirurgie Générale - Hôpitaux Civils de Lyon 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 d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine 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 de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet Pierre Benite
France Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque Rennes
France Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux 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 les 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 Vandoeuvre les Nancy
France Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne Vandoeuvre les Nancy

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Bordeaux Roche Pharma AG, Sanofi

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect 24 months
Secondary 5-year survival. 5 years
Secondary Quality of life (QLQ C30 - CR38) at 0, 4, 8 and 12 months
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