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

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NCT00143403

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Study Location
Pfizer Investigational Site
Gent, , 9000, Belgium
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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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.

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Colorectal Neoplasms, Liver NeoplasmsComparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
NCT00143403
  1. Gent,
  2. Roeselare,
  3. Copenhagen,
  4. Herlev,
  5. Odense,
  6. Amiens cedex 1,
  7. Avignon,
  8. Boulogne Billancourt cedex,
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  10. Colmar,
  11. Grenoble Cedex 09,
  12. Marseille Cedex 9,
  13. Marseille,
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  15. Montpellier Cedex 5,
  16. Montpellier,
  17. Nice,
  18. Nimes,
  19. Rennes,
  20. Strasbourg,
  21. Toulouse cedex,
  22. Cottbus,
  23. Dessau,
  24. Erlangen,
  25. Hamburg,
  26. Leipzig,
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  30. Oldenburg,
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  35. Petach-Tikva,
  36. Rehovot,
  37. Tel-Aviv,
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  39. Carpi, Modena
  40. Brescia,
  41. Latisana, UD,
  42. Padova,
  43. Parma,
  44. Piacenza,
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  48. Goyang,
  49. Seoul,
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ALL GENDERS
18 Years+
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Colorectal Neoplasms, Liver NeoplasmsNeoadjuvant Colorectal Cancer With Unresectable Liver Metastases
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  1. New York, New York
  2. Philadelphia, Pennsylvania
ALL GENDERS
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Advanced Information
Descriptive Information
Brief Title  ICMJE Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
Official Title  ICMJE 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.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Neoplasms
  • Liver Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Irinotecan + 5 FU + folinic acid
  • Active Comparator: 2
    Intervention: Drug: Folinic Acid + 5 FU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)		321
Original Enrollment  ICMJE
 (submitted: September 1, 2005)		420
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Denmark,   France,   Germany,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Portugal,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143403
Other Study ID Numbers  ICMJE CPT-GMA-301
A5961076
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP