CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

December 4, 2009 updated by: Sanofi

Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Diegem, Belgium
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Germany
      • Frankfurt, Germany
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milan, Italy
        • Sanofi-Aventis Administrative Office
  • Netherlands
      • Pe Gouda, Netherlands
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • United Kingdom
      • Guildford Surrey, United Kingdom
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge)
  • No evidence of distant spread
  • No prior therapy for chemotherapy or radiation therapy for rectal cancer

  • Patient considered locally advanced by MRI:

    • Tumour beyond mesorectal fascia, or
    • Tumour ≤ 2mm from mesorectal fascia, or
    • T3 tumour < 5cm from anal verge
  • For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
  • No peripheral neuropathy > grade1
  • ECOG PS ≤ 2
  • ANC > 1,500 x 10^9/L
  • Platelets > 100,000 x 10^9/L
  • Creatinine < 1.5 x IULN
  • Bilirubin < 1.5 IULN
  • SGPT (ALT) < 2.5 IULN
  • No pre-existing condition which would deter chemoradiotherapy
  • No uncontrolled diarrhoea or fecal incontinence
  • No significant small bowel (> 200cc or 6X6X6cm) delineated within the radiation fields
  • No other serious uncontrolled concomitant illness
  • Informed consent signed

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRI staging and TME surgery
Time Frame: within 4 - 6 weeks after completion XELOX-RT
within 4 - 6 weeks after completion XELOX-RT

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure safety - NCI-CTC version 2
Time Frame: from baseline to end of study
from baseline to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C_8601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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