Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma

Rectal Cancer Clinical Trial

— GRECCAR1  

Official title:

Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979680
• Other study ID #: KBR-2001
• Status: Completed
• Phase: Phase 3
• Start date: April 2001
• Est. completion date: September 2007

Study information

• Verified date: June 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation
• Tumor classified as EER UT2-UT3, whatever the nodal status
• pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani.
• Age 18 years or older
• Informed and written consent

Exclusion Criteria:

• T1
• T4 (proven invasion of sphincter)
• Diffuse metastatic syndrome (no curative intent, short expected life span)
• preoperative incontinence (non due to the tumor)

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• High-Dose radiotherapy
Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks.
• Chemo-radiotherapy
Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.

Locations

Country	Name	City	State
France	Institut Sainte catherine	Avignon
France	Hopital Saint Andre	Bordeaux
France	Hotel Dieu	Clermont-Ferrand
France	Hopital Michallon	Grenoble
France	Centre Oscar Lambret	Lille
France	CAC Léon Bérard	Lyon
France	Institut Paoli Calmettes	Marseille
France	CRLC Val d'Aurelle	Montpellier
France	Hopital Saint Eloi	Montpellier
France	Centre Rene Gauducheau	Nantes
France	Centre Paul Strauss	Strasbourg
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sphincter preservation rate		surgery
Secondary	Tumor response according to rectal endo-echography		prior to surgery
Secondary	operative mortality and morbidity		after surgery
Secondary	anatomopathology margins (lateral and inferior)		after surgery
Secondary	Functional results (stoma closure, continence, manometry)		2 years
Secondary	Local recurrence		3 years
Secondary	Disease-free survival		3 years
Secondary	Overall Survival		4 years