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OpenTrials
Completed

NCT Number: NCT00143403

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Irinotecan + 5 FU + folinic acid

Drug

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 FU

Drug

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

Primary outcomes

  1. Disease Free Survival (DFS)

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

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

Secondary outcomes

  1. Overall Survival Rates

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

    Probability of being alive was calculated in a yearly increment.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.

Important dates

Study start
2001
Primary completion
2008
Study completion
2009
First posted
Sep 2, 2005
Registry last updated
Sep 28, 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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