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

NCT ID: NCT00156975

Last Updated: 2009-12-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30

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,

Conditions

Colorectal Neoplasms; Liver Metastases

Keywords

Oxaliplatin; Capecitabine; Chemotherapy; Resection; Liver metastases; Liver resection; Adjuvant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Capecitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arbeitsgruppe Lebermetastasen und Tumoren

OTHER

Sponsor Role: lead

Principal Investigators

Wolf O. Bechstein, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Arbeitsgruppe Lebermetastasen und Tumoren

Locations

Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik

Dresden, Saxony, Germany

Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II

Essen, , Germany

Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität

Frankfurt am Main, , Germany

Countries

Germany

Other Identifiers

ADHOC

Identifier Type: -

Identifier Source: org_study_id