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

Pfizer321 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

321

Conditions

Colorectal Neoplasms Liver Neoplasms

Interventions

Irinotecan + 5 FU + folinic acidDRUG

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

Folinic Acid + 5 FUDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour. * Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion. * Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases. Exclusion Criteria: * Prior hepatic radiation or resection. * Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es). * Prior chemotherapy for metastatic disease.

Locations (66)

Outcomes

Primary Outcomes

Disease Free Survival (DFS)

time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.

Time frame: last tumor assessment date or cut-off date, whichever is earlier.

Secondary Outcomes

Overall Survival Rates

Probability of being alive was calculated in a yearly increment.

Time frame: Median follow-up time (42 months)

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Ghent, Belgium

Pfizer Investigational Site

Roeselare, Belgium

Pfizer Investigational Site

Copenhagen, Denmark

Pfizer Investigational Site

Herlev, Denmark

Pfizer Investigational Site

Odense, Denmark

Pfizer Investigational Site

Amiens, France

Pfizer Investigational Site

Avignon, France

Pfizer Investigational Site

Boulogne-Billancourt, France

Pfizer Investigational Site

Clermont-Ferand Cedex 1, France

Pfizer Investigational Site

Colmar, France

...and 56 more locations