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CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174616
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 7, 2009
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Brief 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

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Drug: Oxaliplatin, capecitabine, radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer
Study Start Date : July 2003
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. MRI staging and TME surgery [ Time Frame: within 4 - 6 weeks after completion XELOX-RT ]

Secondary Outcome Measures :
  1. Measure safety - NCI-CTC version 2 [ Time Frame: from baseline to end of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00174616

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Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Pe Gouda, Netherlands
Sanofi-Aventis Administrative Office
Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
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Study Director: Jean-Philippe Aussel Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00174616     History of Changes
Other Study ID Numbers: C_8601
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents