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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
High-Dose radiotherapy
Chemo-radiotherapy
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring sphincter preservation, neoadjuvant therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institut Sainte catherine
  • Hopital Saint Andre
  • Hotel Dieu
  • Hopital Michallon
  • Centre Oscar Lambret
  • CAC Léon Bérard
  • Institut Paoli Calmettes
  • CRLC Val d'Aurelle
  • Hopital Saint Eloi
  • Centre Rene Gauducheau
  • Centre Paul Strauss
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High-dose Radiotherapy

Chemo-radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Sphincter preservation rate

Secondary Outcome Measures

Tumor response according to rectal endo-echography
operative mortality and morbidity
anatomopathology margins (lateral and inferior)
Functional results (stoma closure, continence, manometry)
Local recurrence
Disease-free survival
Overall Survival

Full Information

First Posted
September 17, 2009
Last Updated
June 28, 2023
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT00979680
Brief Title
Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma
Acronym
GRECCAR1
Official Title
Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
sphincter preservation, neoadjuvant therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-dose Radiotherapy
Arm Type
Active Comparator
Arm Title
Chemo-radiotherapy
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
High-Dose radiotherapy
Other Intervention Name(s)
HDRT
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Chemo-radiotherapy
Other Intervention Name(s)
CTRT
Intervention Description
Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.
Primary Outcome Measure Information:
Title
Sphincter preservation rate
Time Frame
surgery
Secondary Outcome Measure Information:
Title
Tumor response according to rectal endo-echography
Time Frame
prior to surgery
Title
operative mortality and morbidity
Time Frame
after surgery
Title
anatomopathology margins (lateral and inferior)
Time Frame
after surgery
Title
Functional results (stoma closure, continence, manometry)
Time Frame
2 years
Title
Local recurrence
Time Frame
3 years
Title
Disease-free survival
Time Frame
3 years
Title
Overall Survival
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Rouanet, Pr
Organizational Affiliation
CRLC Val d'Aurelle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Sainte catherine
City
Avignon
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
Country
France
Facility Name
Hotel Dieu
City
Clermont-Ferrand
Country
France
Facility Name
Hopital Michallon
City
Grenoble
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
CAC Léon Bérard
City
Lyon
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
CRLC Val d'Aurelle
City
Montpellier
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier
Country
France
Facility Name
Centre Rene Gauducheau
City
Nantes
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

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

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