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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00979680
First Posted: September 18, 2009
Last Update Posted: September 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institut du Cancer de Montpellier - Val d'Aurelle
  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
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Institut du Cancer de Montpellier - Val d'Aurelle:

Primary Outcome Measures:
  • Sphincter preservation rate [ Time Frame: surgery ]

Secondary Outcome Measures:
  • Tumor response according to rectal endo-echography [ Time Frame: prior to surgery ]
  • operative mortality and morbidity [ Time Frame: after surgery ]
  • anatomopathology margins (lateral and inferior) [ Time Frame: after surgery ]
  • Functional results (stoma closure, continence, manometry) [ Time Frame: 2 years ]
  • Local recurrence [ Time Frame: 3 years ]
  • Disease-free survival [ Time Frame: 3 years ]
  • Overall Survival [ Time Frame: 4 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Principal Investigator: Philippe Rouanet, Pr CRLC Val d'Aurelle
  More Information

Responsible Party: Pr Philippe Rouanet, CRLC Val d'Aurelle
ClinicalTrials.gov Identifier: NCT00979680     History of Changes
Other Study ID Numbers: KBR-2001
First Submitted: September 17, 2009
First Posted: September 18, 2009
Last Update Posted: September 21, 2009
Last Verified: September 2009

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
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