Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases

Colorectal Neoplasms Clinical Trial

Official title: Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study

Status Active, not recruiting

Clinical Trial Summary

Primary endpoint of the study is to prove the superiority of an adjuvant therapy with oxaliplatin/ capecitabine until the first occurrence of appearance of a tumour. Occurrences in the meaning of this study are the appearance of a relapse of the tumour, of metastases, of a second tumour or death of any reason.

Clinical Trial Description

Prospective, randomized, multi-centre, open phase III study with two parallel groups of patients according to the eligibility criteria. The times in both hierarchical classified endpoints will be measured as times from randomization.

Patients with macroscopic complete resection of colorectal liver metastases will be randomized in:

Arm A: post-operative adjuvant therapy with Capecitabine/ Oxaliplatin over 6 months and follow-up

or

Arm B: follow-up

Randomization: stratification after Scores of Fong et al:

• number of metastases (1 vs. >=1)

• maximal diameter of the metastasis (<= 5cm vs. > 5cm)

• disease free interval (>= 12 months vs. > 12 months)

• CEA (<= 200ng/l vs. >200 ng/l) in the strata 0-1, 2 and >= 3, ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

• NCT number: NCT00156975
• Study type: Interventional
• Source: Arbeitsgruppe Lebermetastasen und Tumoren
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2004