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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgruppe Lebermetastasen und Tumoren
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• patients after R0-resection of colorectal liver metastases

• age: >= 18 years

• Karnofsky-Index >= 70%

• neutrophiles >1,5 x10e9/l, thrombocytes 100 x10e9/l

• adequate contraception for male and female patients

• oral and written informed consent (GCP)

Exclusion Criteria:

• other prior malignancies, except treated in situ-carcinoma of cervix or tumours of skin without indication to a melanoma (or 10 years tumourfree)

• other participation in clinical trials within 30 days before randomization

• previous chemotherapy (except adjuvant chemotherapy with an interval of >= 6 months)

• creatinine clearance <50 ml/min

• hepatic insufficiency (ALAT, ASAT, Bilirubin, AP >5 x upper limit)

• peripheral neuropathy > CTC grade 1

• uncontrolled cardiac insufficiency or angina pectoris

• active infections

• severe neurological or psychiatric illness

• breast-feeding or pregnant women

• incapacity to take part in regular visits