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CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174616
First received: September 9, 2005
Last updated: December 4, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Rectal Neoplasms
 Drug: Oxaliplatin, capecitabine, radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • MRI staging and TME surgery [ Time Frame: within 4 - 6 weeks after completion XELOX-RT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure safety - NCI-CTC version 2 [ Time Frame: from baseline to end of study ] [ Designated as safety issue: Yes ]

Enrollment: 87
Study Start Date: July 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174616

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174616     History of Changes
Other Study ID Numbers: C_8601
Study First Received: September 9, 2005
Last Updated: December 4, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
 Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013