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Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer

NCT00143403 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2010-09-28

Study results available
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Summary

To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.

Conditions

  • Colorectal Neoplasms
  • Liver Neoplasms

Interventions

DRUG

Irinotecan + 5 FU + folinic acid

irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks

DRUG

Folinic Acid + 5 FU

folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2008-02-29
Completion
2009-09-30

Countries

  • Belgium
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • Portugal
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00143403 on ClinicalTrials.gov