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

Last updated: June 28, 2023
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Overall Status: Completed

Phase

3

Condition

Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

High-Dose radiotherapy

Chemo-radiotherapy

Clinical Study ID

NCT00979680
KBR-2001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 distantmetastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement andwith the inferior margin of the tumor located less than 2 cm from the upper part ofthe levator ani.
  • Age 18 years or older
  • Informed and written consent

Exclusion

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 Design

Total Participants: 207
Treatment Group(s): 2
Primary Treatment: High-Dose radiotherapy
Phase: 3
Study Start date:
April 01, 2001
Estimated Completion Date:
September 30, 2007

Connect with a study center

  • Institut Sainte catherine

    Avignon,
    France

    Site Not Available

  • Hopital Saint Andre

    Bordeaux,
    France

    Site Not Available

  • Hotel Dieu

    Clermont-Ferrand,
    France

    Site Not Available

  • Hopital Michallon

    Grenoble,
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille,
    France

    Site Not Available

  • CAC Léon Bérard

    Lyon,
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille,
    France

    Site Not Available

  • CRLC Val d'Aurelle

    Montpellier,
    France

    Site Not Available

  • Hopital Saint Eloi

    Montpellier,
    France

    Site Not Available

  • Centre Rene Gauducheau

    Nantes,
    France

    Site Not Available

  • Centre Paul Strauss

    Strasbourg,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif,
    France

    Site Not Available

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