Local Excision in Downstaged Rectal Cancer
- Conditions
- Rectal Neoplasms
- Interventions
- Procedure: total mesorectal excisionProcedure: local rectal excision
- Registration Number
- NCT00427375
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 total mesorectal excision Standard surgery 1 local rectal excision New surgical option in good responders after neoadjuvant treatment for low rectal cancer
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (40)
Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet
🇫🇷Agen, France
Polyclinique Sainte marguerite
🇫🇷Auxerre, 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 Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming
🇫🇷Besançon, 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
Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc
🇫🇷Clichy, France
Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert
🇫🇷Clermont-Ferrand, 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
Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre
🇫🇷Marseille, France
Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose
🇫🇷Nice, France
Institut Paoli Calmette
🇫🇷Marseille, France
Département de Chirurgie Oncologique - CRLC Val d'Aurelle
🇫🇷Montpellier, France
CHU Nantes
🇫🇷Nantes, France
Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré
🇫🇷Paris, France
CHU Nîmes
🇫🇷Nîmes, France
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine
🇫🇷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 d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine
🇫🇷Paris, 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 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
Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens
🇫🇷Rouen, France
Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital
🇫🇷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, France
Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer
🇫🇷La Rochelle, France
Service de Chirurgie Générale - Hôpital Archet II
🇫🇷Nice, France
Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet
🇫🇷Pierre Benite, France
Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont
🇫🇷Rouen, France
Service de Chirurgie Digestive - Hôpital Hautepierre
🇫🇷Strasbourg, France