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

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NCT00143403

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Gent, , 9000 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms, Liver Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior hepatic radiation or resection.

- Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver
metastasis (es).

- Prior chemotherapy for metastatic disease.

NCT00143403
Pfizer
Completed
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer

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[email protected]

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Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colorectal Neoplasms
  • Liver Neoplasms
  • 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
  • Experimental: 1
    Intervention: Drug: Irinotecan + 5 FU + folinic acid
  • Active Comparator: 2
    Intervention: Drug: Folinic Acid + 5 FU
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
September 2009
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   France,   Germany,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Portugal,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Ukraine,   United Kingdom
 
 
NCT00143403
CPT-GMA-301
A5961076
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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