Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study
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
Arm A: post-operative adjuvant therapy with Capecitabine/ Oxaliplatin over 6 months and
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,
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Wolf O. Bechstein, Prof. Dr.
Arbeitsgruppe Lebermetastasen und Tumoren
Germany: Federal Institute for Drugs and Medical Devices