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Oxaliplatin in Rectal Cancer

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: NCT00259363
Recruitment Status : Terminated (Study cancelled because recruitment rate was too slow)
First Posted : November 29, 2005
Last Update Posted : December 7, 2009
Information provided by:

Brief Summary:
  • 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 or disease Intervention/treatment Phase
Rectal Neoplasms Drug: Oxaliplatin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer
Study Start Date : October 2002
Actual Primary Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

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

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

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 to 80 Years   (Adult, Older Adult)
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.

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): NCT00259363

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

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00259363    
Other Study ID Numbers: L_8330
First Posted: November 29, 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
Antineoplastic Agents