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

Sponsored by:	Arbeitsgruppe Lebermetastasen und Tumoren
Information provided by:	Arbeitsgruppe Lebermetastasen und Tumoren
ClinicalTrials.gov Identifier:	NCT00156975

Purpose

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

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Oxaliplatin Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study

Further study details as provided by Arbeitsgruppe Lebermetastasen und Tumoren:

Primary Outcome Measures:

Primary outcomes:
Disease free survival

Secondary Outcome Measures:

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

Estimated Enrollment:	384
Study Start Date:	November 2004

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,

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156975

Locations

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

Sponsors and Collaborators

Arbeitsgruppe Lebermetastasen und Tumoren

Investigators

Principal Investigator:

Wolf O. Bechstein, Prof. Dr.

Arbeitsgruppe Lebermetastasen und Tumoren

More Information

Additional Information:

Hompage Arbeitsgruppe Lebermetastasen und Tumoren This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	ADHOC
Study First Received:	September 9, 2005
Last Updated:	April 13, 2007
ClinicalTrials.gov Identifier:	NCT00156975 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Arbeitsgruppe Lebermetastasen und Tumoren:

Oxaliplatin
Capecitabine
Chemotherapy
Resection

Liver metastases
Liver resection
Adjuvant

Study placed in the following topic categories:

Antimetabolites
Liver Diseases
Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Adjuvants, Immunologic
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Liver Neoplasms
Oxaliplatin
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Liver Diseases
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions

Intestinal Neoplasms
Liver Neoplasms
Oxaliplatin
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009