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

NCT00979680 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2023-06-29

No results posted yet for this 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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Philippe Rouanet, Pr · CRLC Val d'Aurelle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Completion
2007-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00979680 on ClinicalTrials.gov