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Completed

NCT Number: NCT00403624

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

Primary objective:

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

Secondary objective:

- tolerability (toxicity) and time to progression

Completed

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxaliplatin

Drug

Primary outcomes

  1. Tumour response

Secondary outcomes

  1. Disease free and Overall survival ; Adverse events

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Nov 27, 2006
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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