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Sponsored by: |
Arbeitsgruppe Lebermetastasen und Tumoren |
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Information provided by: | Arbeitsgruppe Lebermetastasen und Tumoren |
ClinicalTrials.gov Identifier: | NCT00156975 |
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 |
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Colorectal Neoplasms Liver Metastases |
Drug: Capecitabine Drug: Oxaliplatin |
Phase III |
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 |
Estimated Enrollment: | 384 |
Study Start Date: | November 2004 |
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Wolf O. Bechstein, Prof. Dr. | Arbeitsgruppe Lebermetastasen und Tumoren |
Study ID Numbers: | ADHOC |
Study First Received: | September 9, 2005 |
Last Updated: | April 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00156975 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Oxaliplatin Capecitabine Chemotherapy Resection |
Liver metastases Liver resection Adjuvant |
Capecitabine Liver Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Liver neoplasms Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Liver Neoplasms Oxaliplatin Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Neoplastic Processes Neoplasms Antimetabolites, Antineoplastic Pathologic Processes |
Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |