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

Phase 3

• Conditions: Colorectal Neoplasms; Liver Metastases

• Registration Number: NCT00156975
• Lead Sponsor: Arbeitsgruppe Lebermetastasen und Tumoren

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 study are the appearance of a relapse of the tumour, of metastases, of a second tumour or death of any reason.

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 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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Status Verified: 2007-04
• Last Update Submitted: 2009-12-24
• Last Update Posted: 2009-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary outcomes:
Disease free survival

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity

Trial Locations

Locations (3)

Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II; 🇩🇪 Essen, Germany

Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik; 🇩🇪 Dresden, Sachsen, Germany

Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität; 🇩🇪 Frankfurt Am Main, Germany