Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma (GRECCAR1)

This study has been completed.
Sponsor:
Information provided by:
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT00979680
First received: September 17, 2009
Last updated: September 18, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Radiation: High-Dose radiotherapy
Radiation: Chemo-radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy

Resource links provided by NLM:


Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:
  • Sphincter preservation rate [ Time Frame: surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response according to rectal endo-echography [ Time Frame: prior to surgery ] [ Designated as safety issue: No ]
  • operative mortality and morbidity [ Time Frame: after surgery ] [ Designated as safety issue: Yes ]
  • anatomopathology margins (lateral and inferior) [ Time Frame: after surgery ] [ Designated as safety issue: No ]
  • Functional results (stoma closure, continence, manometry) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Local recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 207
Study Start Date: April 2001
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: High-dose Radiotherapy 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.
Other Name: HDRT
Active Comparator: Chemo-radiotherapy Radiation: 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.
Other Name: CTRT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979680

Locations
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, France
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Principal Investigator: Philippe Rouanet, Pr CRLC Val d'Aurelle
  More Information

No publications provided

Responsible Party: Pr Philippe Rouanet, CRLC Val d'Aurelle
ClinicalTrials.gov Identifier: NCT00979680     History of Changes
Other Study ID Numbers: KBR-2001
Study First Received: September 17, 2009
Last Updated: September 18, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:
sphincter preservation
neoadjuvant therapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014