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.

Condition	Intervention	Phase
Colorectal Neoplasms Liver Metastases	Drug: Capecitabine  Drug: Oxaliplatin	Phase III

Further Study Details: 

Primary Outcomes: Primary outcomes:; Disease free survival
Secondary Outcomes: Secondary outcomes:; -overall survival; -acute- and longtime toxicity of chemotherapy; -molecular predictive markers for the risk of relapse and toxicity
Expected Total Enrollment:  384

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 metastase (<= 5cm vs. > 5cm)
• disease free intervall (>= 12 months vs. > 12 months)
• CEA (<= 200ng/l vs. >200 ng/l) in the strata 0-1, 2 and >= 3,

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00156975

Wolf O. Bechstein, Prof. Dr.      0049 (0)69 6301  Ext. 5251    wolf.bechstein@kgu.de
Christiane Gog, Dr.      0049 (0)69 6301  Ext. 4167    gog@em.uni-frankfurt.de

Germany
      Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität, Frankfurt am Main,  60590,  Germany; Recruiting
      Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II, ESSEN,  45122,  Germany; Recruiting
Germany, Sachsen
      Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik, Dresden,  Sachsen,  011307,  Germany; Recruiting

Study chairs or principal investigators

Wolf O. Bechstein, Prof. Dr.,  Principal Investigator,  Arbeitsgruppe Lebermetastasen und Tumoren   

Study ID Numbers:  ADHOC
Last Updated:  September 10, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00156975
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13