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Oxaliplatin in Rectal Cancer

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

Condition Intervention Phase
Rectal Neoplasms Drug: Oxaliplatin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Phase I : Maximum Tolerated Dose & Recommended Dose [ Time Frame: Days 1, 15, 29 ]
  • Phase II : Response and resectability rate. [ Time Frame: 6 cycles in 6 months ]

Enrollment: 46
Study Start Date: October 2002
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oxaliplatin
    oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00259363

Barcelona, Spain
Sponsors and Collaborators
Study Director: José Mª Taboada Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00259363     History of Changes
Other Study ID Numbers: L_8330
Study First Received: November 28, 2005
Last Updated: December 4, 2009

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents processed this record on July 25, 2017