NCT00979680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

First QC Date

September 17, 2009

Last Update Submit

June 28, 2023

Conditions

Rectal Cancer

Keywords

sphincter preservationneoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • Sphincter preservation rate

    surgery

Secondary Outcomes (7)

  • Tumor response according to rectal endo-echography

    prior to surgery

  • operative mortality and morbidity

    after surgery

  • anatomopathology margins (lateral and inferior)

    after surgery

  • Functional results (stoma closure, continence, manometry)

    2 years

  • Local recurrence

    3 years

  • +2 more secondary outcomes

Study Arms (2)

High-dose Radiotherapy

ACTIVE COMPARATOR
Radiation: High-Dose radiotherapy

Chemo-radiotherapy

ACTIVE COMPARATOR
Radiation: Chemo-radiotherapy

Interventions

High-Dose radiotherapyRADIATION

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.

Also known as: HDRT
High-dose Radiotherapy
Chemo-radiotherapyRADIATION

Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy.

Also known as: CTRT
Chemo-radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • T4 (proven invasion of sphincter)
  • Diffuse metastatic syndrome (no curative intent, short expected life span)
  • preoperative incontinence (non due to the tumor)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Institut Sainte catherine

Avignon, France

Location

Hopital Saint Andre

Bordeaux, France

Location

Hotel Dieu

Clermont-Ferrand, France

Location

Hopital Michallon

Grenoble, France

Location

Centre Oscar Lambret

Lille, France

Location

CAC Léon Bérard

Lyon, France

Location

Institut Paoli Calmettes

Marseille, France

Location

CRLC Val d'Aurelle

Montpellier, France

Location

Hopital Saint Eloi

Montpellier, France

Location

Centre Rene Gauducheau

Nantes, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Institut Gustave Roussy

Villejuif, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Philippe Rouanet, Pr

    CRLC Val d'Aurelle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

April 1, 2001

Study Completion

September 1, 2007

Last Updated

June 29, 2023

Record last verified: 2023-06

Locations

FR(12)