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

December 24, 2009 updated by: Arbeitsgruppe Lebermetastasen und Tumoren

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

384

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease free survival
Primary outcomes:

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgruppe Lebermetastasen und Tumoren

Investigators

  • Principal Investigator: Wolf O. Bechstein, Prof. Dr., Arbeitsgruppe Lebermetastasen und Tumoren

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

December 25, 2009

Last Update Submitted That Met QC Criteria

December 24, 2009

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADHOC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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