Clinical trial NCT00427375: Local Excision in Downstaged Rectal Cancer
Official title: Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Neoplasms
Keywords: Rectal cancer surgery
Neoadjuvant radiochemotherapy
Randomized clinical trial
Multicenter study
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Roche Pharma AG
First posted: 2007-01-29
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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
timeFrame: 24 months
Secondary outcomes:
measure: Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect
timeFrame: 24 months
measure: 5-year survival.
timeFrame: 5 years
measure: Quality of life (QLQ C30 - CR38)
timeFrame: at 0, 4, 8 and 12 months
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet
city: Auxerre
country: France
facility: Polyclinique Sainte marguerite
city: Besançon
country: France
facility: Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming
city: Bordeaux
country: France
facility: Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron
city: Bordeaux
country: France
facility: Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet
city: Bordeaux
country: France
facility: Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne
city: Boulogne Billancourt
country: France
facility: Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle
city: Clermont-Ferrand
country: France
facility: Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt
city: Clermont-Ferrand
country: France
facility: Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert
city: Clichy
country: France
facility: Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc
city: La Rochelle
country: France
facility: Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer
city: La Tronche
country: France
facility: Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne
city: Lille
country: France
facility: Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale
city: Lyon
country: France
facility: Service de Chirurgie Générale - Hôpitaux Civils de Lyon
city: Lyon
country: France
facility: Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Marseille
country: France
facility: Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre
city: Montpellier
country: France
facility: Département de Chirurgie Oncologique - CRLC Val d'Aurelle
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose
city: Nice
country: France
facility: Service de Chirurgie Générale - Hôpital Archet II
city: Nîmes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré
city: Paris
country: France
facility: Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux
city: Paris
country: France
facility: Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron
city: Paris
country: France
facility: Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine
city: Paris
country: France
facility: Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine
city: Pierre Benite
country: France
facility: Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet
city: Rennes
country: France
facility: Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux
city: Rennes
country: France
facility: Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque
city: Rouen
country: France
facility: Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont
city: Rouen
country: France
facility: Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens
city: Saint Herblain
country: France
facility: Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod
city: Sainte Foy les Lyon
country: France
facility: Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot
city: Strasbourg
country: France
facility: Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive - Hôpital Hautepierre
city: Toulouse
country: France
facility: Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre
city: Toulouse
country: France
facility: Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac
city: Vandoeuvre les Nancy
country: France
facility: Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne
city: Vandoeuvre les Nancy
country: France
facility: Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne
Study officials:
affiliation: University Hospital, Bordeaux
name: Eric RULLIER, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.