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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Arbeitsgruppe Lebermetastasen und Tumoren.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Arbeitsgruppe Lebermetastasen und Tumoren
ClinicalTrials.gov Identifier:
NCT00156975
First received: September 9, 2005
Last updated: December 24, 2009
Last verified: April 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study

Resource links provided by NLM:

U.S. FDA Resources

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
Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
Dresden, Sachsen, Germany, 011307
Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II
Essen, Germany, 45122
Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität
Frankfurt Am Main, Germany, 60590
Sponsors and Collaborators
Arbeitsgruppe Lebermetastasen und Tumoren
Investigators
Principal Investigator: Wolf O. Bechstein, Prof. Dr. Arbeitsgruppe Lebermetastasen und Tumoren
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00156975     History of Changes
Other Study ID Numbers: ADHOC
Study First Received: September 9, 2005
Last Updated: December 24, 2009
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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
 Pathologic Processes
Liver Diseases
Oxaliplatin
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013