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Influence of Lengthening the Interval Between Radiochemotherapy and Surgery on Complete Pathological Response in Rectal Cancer

NCT01648894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2022-07-25

No results posted yet for this study

Summary

At the end of the neoadjuvant radiochemotherapy, patients are seen by their surgeon to planify the surgery. During this visit, the study will be explained them and their consent obtained. They will then be randomized between the two groups 7 weeks vs. 11 weeks. Patients were reviewed 15 days before surgery and at 1 and 3 months after surgery. Participation in this study does not change treatment, investigations and consultations usually necessary for management of rectal cancer. The objective is to improve the pathological complete response rate of the rectal cancer.

Conditions

Interventions

PROCEDURE

Surgery after 11 weeks of delay after chemoradiotherapy.

Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 11 weeks of delay after the end of chemoradiotherapy.

PROCEDURE

Surgery after 7 weeks of delay after chemoradiotherapy

Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 7 weeks of delay after the end of chemoradiotherapy

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jérémie Lefèvre, MD · Assistance Publique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-25
Primary Completion
2015-10-22
Completion
2020-05-06

Countries

  • France

Study Locations

More Related Trials

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 NCT01648894 on ClinicalTrials.gov