Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study
18 Years
N/A
Both
Colorectal Neoplasms, Liver Metastases
Trial Information
Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study
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,
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary outcomes:
Principal Investigator
Wolf O. Bechstein, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Arbeitsgruppe Lebermetastasen und Tumoren
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
ADHOC
NCT ID:
NCT00156975
Start Date:
November 2004
Completion Date:
Related Keywords:
- Colorectal Neoplasms
- Liver Metastases
- Oxaliplatin
- Capecitabine
- Chemotherapy
- Resection
- Liver metastases
- Liver resection
- Adjuvant
- Neoplasms
- Colorectal Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Liver Neoplasms
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