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

Study Overview
=================
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,

Official Title
-----------------
Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study

Conditions
-----------------
Colorectal Neoplasms, Liver Metastases

Intervention / Treatment
-----------------
* Drug: Capecitabine
* Drug: Oxaliplatin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine|nan|
|Drug: Oxaliplatin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcomes: |  |  | 
| Disease free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxaliplatin, Capecitabine, Chemotherapy, Resection, Liver metastases, Liver resection, Adjuvant