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

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)

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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