- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00156975
Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases
Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study
Study Overview
Status
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
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Essen, Germany, 45122
- Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II
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Frankfurt Am Main, Germany, 60590
- Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität
-
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Sachsen
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Dresden, Sachsen, Germany, 011307
- Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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
Investigators
- Principal Investigator: Wolf O. Bechstein, Prof. Dr., Arbeitsgruppe Lebermetastasen und Tumoren
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Liver Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Liver Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
- Oxaliplatin
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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