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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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Pfizer

Status and phase

Completed
Phase 3

Conditions

Liver Neoplasms
Colorectal Neoplasms

Treatments

Drug: Folinic Acid + 5 FU
Drug: Irinotecan + 5 FU + folinic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00143403
CPT-GMA-301
A5961076

Details and patient eligibility

About

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.

Enrollment

321 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

321 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: Irinotecan + 5 FU + folinic acid
2
Active Comparator group
Treatment:
Drug: Folinic Acid + 5 FU

Trial contacts and locations

66

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Data sourced from clinicaltrials.gov

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