Clinical trial NCT00156975: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Neoplasms
Liver Metastases
Keywords: Oxaliplatin
Capecitabine
Chemotherapy
Resection
Liver metastases
Liver resection
Adjuvant
Lead sponsor: Arbeitsgruppe Lebermetastasen und Tumoren
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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,

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

Primary outcomes:
measure: Primary outcomes:
measure: Disease free survival
Secondary outcomes:
measure: Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
state: Sachsen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II
city: Frankfurt Am Main
country: Germany
facility: Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität
Study officials:
affiliation: Arbeitsgruppe Lebermetastasen und Tumoren
name: Wolf O. Bechstein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: