Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer - Full Text View

Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer

This study has been completed.

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00403624

Purpose

Primary objective:

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

Secondary objective:

- tolerability (toxicity) and time to progression

Condition	Intervention	Phase
Rectal Neoplasms	Drug: OXALIPLATIN	Phase I Phase II

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Clinical Study to Evaluate a Protocol of Oxaliplatin -UFT- Radiotherapy for the Neoadjuvant Treatment Rectal Cancer

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Tumour response

Secondary Outcome Measures:

Disease free and Overall survival ; Adverse events

Estimated Enrollment:	38
Study Start Date:	July 2001

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403624

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	José Mª Taboada, Dr.	Sanofi-Aventis

More Information

CSR Synopsis This link exits the ClinicalTrials.gov site

Study ID Numbers:	L_8128
First Received:	November 23, 2006
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00403624
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Oxaliplatin

Digestive System Diseases

Digestive System Neoplasms

Gastrointestinal Diseases

Rectal Neoplasms

Gastrointestinal Neoplasms

Intestinal Diseases

Rectal cancer

Rectal Diseases

Intestinal Neoplasms

Colorectal Neoplasms

Rectal neoplasm

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008