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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

April 13, 2007

Start Date ^†

November 2004

Current Primary Outcome Measures ^†

Primary outcomes:
Disease free survival

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00156975 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study

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

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^†

Colorectal Neoplasms
Liver Metastases

Intervention ^†

Drug: Capecitabine
Drug: Oxaliplatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

384

Completion Date

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00156975

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Arbeitsgruppe Lebermetastasen und Tumoren

Collaborators ^††

Investigators ^†

Principal Investigator:

Wolf O. Bechstein, Prof. Dr.

Arbeitsgruppe Lebermetastasen und Tumoren

Information Provided By

Arbeitsgruppe Lebermetastasen und Tumoren

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.