Back to resultsEvaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer
Primary Purpose
Rectal Neoplasms
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
OXALIPLATIN
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Neoplasms
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Tumour response
Secondary Outcome Measures
Disease free and Overall survival ; Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00403624
Brief Title
Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer
Official Title
Clinical Study to Evaluate a Protocol of Oxaliplatin -UFT- Radiotherapy for the Neoadjuvant Treatment Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
Primary objective:
- To evaluate the rate of responses to neoadjuvant therapy + radiotherapy
Secondary objective:
- tolerability (toxicity) and time to progression
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
OXALIPLATIN
Primary Outcome Measure Information:
Title
Tumour response
Secondary Outcome Measure Information:
Title
Disease free and Overall survival ; Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Mª Taboada, Dr.
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer
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