Oxaliplatin in Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00259363
• Other study ID #: L_8330
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 28, 2005
• Last updated: December 4, 2009
• Start date: October 2002

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

• Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study

• Phase II: To determine the treatment efficacy according to response rates from phase I.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 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:

• ECOG: 0-2

• Histological proved rectal adenocarcinoma

• No chemotherapy treatment on the previous 6 months before inclusion.

• No previous pelvic radiotherapy treatment

Exclusion Criteria:

• Important Biological abnormality (renal, hepatic and/or hematological)

• Intestinal occlusion or subocclusion

• Peripheral neuropathy

• Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.

• Participation in other trials on the previous 4 months.

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
oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days

Locations

Country	Name	City	State
Spain	Sanofi-Aventis	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I : Maximum Tolerated Dose & Recommended Dose		Days 1, 15, 29	No
Primary	Phase II : Response and resectability rate.		6 cycles in 6 months	No