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Local Excision in Downstaged Rectal Cancer

NCT00427375 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2018-03-14

No results posted yet for this study

Summary

Patients with T2T3 low rectal cancer (size =\< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =\< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.

Conditions

  • Rectal Neoplasms

Interventions

PROCEDURE

local rectal excision

New surgical option in good responders after neoadjuvant treatment for low rectal cancer

PROCEDURE

total mesorectal excision

standard surgery

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Eric RULLIER, Pr. · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-05
Primary Completion
2014-12-31
Completion
2018-02-08

Countries

  • France

Study Locations

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Entities

Companies

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 NCT00427375 on ClinicalTrials.gov