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

Primary Purpose

Colorectal Neoplasms, Liver Metastases

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Capecitabine
Oxaliplatin
Sponsored by
Arbeitsgruppe Lebermetastasen und Tumoren
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Oxaliplatin, Capecitabine, Chemotherapy, Resection, Liver metastases, Liver resection, Adjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
  • Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II
  • Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität

Outcomes

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

Full Information

First Posted
September 9, 2005
Last Updated
December 24, 2009
Sponsor
Arbeitsgruppe Lebermetastasen und Tumoren
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1. Study Identification

Unique Protocol Identification Number
NCT00156975
Brief Title
Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases
Official Title
Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Arbeitsgruppe Lebermetastasen und Tumoren

4. Oversight

5. Study Description

Brief Summary
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.
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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Liver Metastases
Keywords
Oxaliplatin, Capecitabine, Chemotherapy, Resection, Liver metastases, Liver resection, Adjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
384 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Primary Outcome Measure Information:
Title
Primary outcomes:
Title
Disease free survival
Secondary Outcome Measure Information:
Title
Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolf O. Bechstein, Prof. Dr.
Organizational Affiliation
Arbeitsgruppe Lebermetastasen und Tumoren
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
011307
Country
Germany
Facility Name
Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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