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Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy 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.
 
ClinicalTrials.gov Identifier: NCT00403624
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
Sanofi

Brief Summary:

Primary objective:

- To evaluate the rate of responses to neoadjuvant therapy + radiotherapy

Secondary objective:

- tolerability (toxicity) and time to progression


Condition or disease Intervention/treatment Phase
Rectal Neoplasms Drug: OXALIPLATIN Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate a Protocol of Oxaliplatin -UFT- Radiotherapy for the Neoadjuvant Treatment Rectal Cancer
Study Start Date : July 2001
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin




Primary Outcome Measures :
  1. Tumour response

Secondary Outcome Measures :
  1. Disease free and Overall survival ; Adverse events


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Patients with measurable, histologically proven rectal cancer.
  • No history of previous malignancy but adequately treated skin / cervical cancer.
  • Adequate haematological, renal and liver function.

Exclusion Criteria:

  • No cardiopulmonary insufficiency or coronary disease. No sensory neuropathy prior to study.

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 ClinicalTrials.gov identifier (NCT number): NCT00403624


Sponsors and Collaborators
Sanofi
Investigators
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Study Director: José Mª Taboada, Dr. Sanofi
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ClinicalTrials.gov Identifier: NCT00403624    
Other Study ID Numbers: L_8128
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: April 2008
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents