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CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

NCT00174616 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2009-12-07

No results posted yet for this study

Summary

Primary objective:

* Pathological complete response (ypT0N0) rate

Secondary objectives:

* Histopathological R0 resection rate
* Pathological downstaging (ypT0-T2N0) rate
* One month surgical complication rate
* Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
* Safety
* Local and distant recurrence rates
* Progression-free survival
* Overall survival

Conditions

  • Rectal Neoplasms

Interventions

DRUG

Oxaliplatin, capecitabine, radiotherapy

* Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses * Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks * Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks

Sponsors & Collaborators

Principal Investigators

  • Jean-Philippe Aussel · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT00174616 on ClinicalTrials.gov