Status:
UNKNOWN
Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases
Lead Sponsor:
Arbeitsgruppe Lebermetastasen und Tumoren
Conditions:
Colorectal Neoplasms
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed 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 meas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT00156975
Start Date
November 1 2004
Last Update
December 25 2009
Active Locations (3)
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1
Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
Dresden, Saxony, Germany, 011307
2
Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II
Essen, Germany, 45122
3
Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität
Frankfurt am Main, Germany, 60590