Phase 3
N=321
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
Colorectal Neoplasms · Liver Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00143403 ↗Enrolled (actual)
321
Serious AEs
15.4%
Results posted
Jun 2009
Primary outcome: Primary: Disease Free Survival (DFS) — 21.6; 24.7 months — p=0.468
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Irinotecan + 5 FU + folinic acid (Drug); Folinic Acid + 5 FU (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Free Survival (DFS) |
21.6; 24.7 | 0.468 |
| SECONDARY Overall Survival Rates |
0.961; 0.973; 0.845; 0.881; 0.716; 0.727 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00143403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.