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Local Excision in Downstaged Rectal Cancer

Information source: University Hospital, Bordeaux
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Neoplasms

Intervention: local rectal excision (Procedure); total mesorectal excision (Procedure)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University Hospital, Bordeaux

Official(s) and/or principal investigator(s):
Eric RULLIER, Pr., Principal Investigator, Affiliation: CHU Bordeaux
Genevieve CHENE, Pr., Study Chair, Affiliation: University Hospital, Bordeaux

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: 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

Secondary outcome:

Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect

5-year survival.

Quality of life (QLQ C30 - CR38)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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 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 Radiothérapie - Clinique Tivoli - 220 rue Mandron, Bordeaux 33000, France

Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle, Boulogne Billancourt 92100, France

Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert, Clermont-Ferrand 63011, France

Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt, Clermont-Ferrand 63000, 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

Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec, Lyon 69373, France

Service de Chirurgie Générale - Hôpitaux Civils de Lyon, Lyon 69317, 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 d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine, Paris 75970, 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 de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet, Pierre Benite 69495, France

Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque, Rennes 35042, France

Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux, Rennes 35033, 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 les 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, Vandoeuvre les Nancy 54511, France

Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne, Vandoeuvre les Nancy 54511, France

Additional Information

Starting date: March 2007
Last updated: March 19, 2015

Page last updated: August 23, 2015

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