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

Rectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403624
• Other study ID #: L_8128
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 23, 2006
• Last updated: August 26, 2010
• Start date: July 2001
• Est. completion date: November 2005

Study information

• Verified date: April 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Primary objective:

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

Secondary objective:

• tolerability (toxicity) and time to progression

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Drug:
• OXALIPLATIN

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour response
Secondary	Disease free and Overall survival ; Adverse events