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| Sponsors and Collaborators: |
University Hospital, Bordeaux Sanofi-Synthelabo Hoffmann-La Roche |
|---|---|
| Information provided by: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00427375 |
Purpose
Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant capecitabine 1600mg/m²/day and oxaliplatin 50mg/m²/week). 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Neoplasms |
Procedure: local rectal excision Procedure: total mesorectal excision |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy |
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2014 |
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 50Gy in 5 weeks with concomitant chemotherapy : capecitabine 1600mg/m²/j (5 days/7) and oxaliplatin 50mg/m²/weekly.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eric RULLIER, Pr. | (33) 5 56 79 58 10 | eric.rullier@chu-bordeaux.fr |
| France | |
| Service de chirurgie digestive - hôpital Saint André | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Eric RULLIER, Pr. (33) 5 56 79 58 10 eric.rullier@chu-bordeaux.fr | |
| Service de Chirurgie Digestive - Hôpital A. Michallon - Boulevard de la Chantourne | Not yet recruiting |
| LA TRONCHE, France, 38700 | |
| Contact: Jean-Luc FAUCHERON, Pr. (33) 4 76 76 55 26 JLFaucheron@chu-grenoble.fr | |
| Département de chirurgie oncologique - CRLC Val d'Aurelle | Not yet recruiting |
| Montpellier, France, 34298 | |
| Contact: Philippe ROUANET, Pr. (33) 4 67 61 31 14 philippe.rouanet@valdorel.fnclcc.fr | |
| Principal Investigator: | Eric RULLIER, Pr. | CHU Bordeaux |
| Study Chair: | Genevieve CHENE, Pr. | CHU de Bordeaux |
More Information
| Study ID Numbers: | CHUBX 2006/03, 2005-025 |
| Study First Received: | January 26, 2007 |
| Last Updated: | May 29, 2007 |
| ClinicalTrials.gov Identifier: | NCT00427375 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Rectal cancer surgery Neoadjuvant radiochemotherapy Randomized clinical trial Multicenter study |
|
Rectal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Rectal Neoplasm |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
|
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |