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

June 28, 2023 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France
        • Institut Sainte Catherine
      • Bordeaux, France
        • Hopital Saint André
      • Clermont-Ferrand, France
        • Hotel Dieu
      • Grenoble, France
        • Hôpital Michallon
      • Lille, France
        • Centre Oscar Lambret
      • Lyon, France
        • CAC Léon Bérard
      • Marseille, France
        • Institut Paoli Calmettes
      • Montpellier, France
        • Hopital Saint Eloi
      • Montpellier, France
        • CRLC Val d'Aurelle
      • Nantes, France
        • Centre Rene Gauducheau
      • Strasbourg, France
        • Centre PAUL STRAUSS
      • Villejuif, France
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • CTRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sphincter preservation rate
Time Frame: surgery
surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Principal Investigator: Philippe Rouanet, Pr, CRLC Val d'Aurelle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimated)

September 18, 2009

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBR-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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