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Oxaliplatin in Rectal Cancer

This study has been terminated.
(Study cancelled because recruitment rate was too slow)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00259363
First received: November 28, 2005
Last updated: December 4, 2009
Last verified: December 2009
History of Changes

November 28, 2005
December 4, 2009
October 2002
June 2006   (final data collection date for primary outcome measure)
  • Phase I : Maximum Tolerated Dose & Recommended Dose [ Time Frame: Days 1, 15, 29 ] [ Designated as safety issue: No ]
  • Phase II : Response and resectability rate. [ Time Frame: 6 cycles in 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00259363 on ClinicalTrials.gov Archive Site
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Oxaliplatin in Rectal Cancer
Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer
  • Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
  • Phase II: To determine the treatment efficacy according to response rates from phase I.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Neoplasms
Drug: Oxaliplatin
oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
46
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June 2006   (final data collection date for primary outcome measure)

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

  • ECOG: 0-2
  • Histological proved rectal adenocarcinoma
  • No chemotherapy treatment on the previous 6 months before inclusion.
  • No previous pelvic radiotherapy treatment

Exclusion Criteria:

  • Important Biological abnormality (renal, hepatic and/or hematological)
  • Intestinal occlusion or subocclusion
  • Peripheral neuropathy
  • Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
  • Participation in other trials on the previous 4 months.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00259363
L_8330
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: José Mª Taboada Sanofi
Sanofi
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP