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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Arbeitsgruppe Lebermetastasen und Tumoren.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Arbeitsgruppe Lebermetastasen und Tumoren
ClinicalTrials.gov Identifier:
NCT00156975
First received: September 9, 2005
Last updated: December 24, 2009
Last verified: April 2007

September 9, 2005
December 24, 2009
November 2004
Not Provided
  • Primary outcomes:
  • Disease free survival
Same as current
Complete list of historical versions of study NCT00156975 on ClinicalTrials.gov Archive Site
Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity
  • Secondary outcomes:
  • -overall survival
  • -acute- and longtime toxicity of chemotherapy
  • -molecular predictive markers for the risk of relapse and toxicity
Not Provided
Not Provided
 
Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases
Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study

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.

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,
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Neoplasms
  • Liver Metastases
  • Drug: Capecitabine
  • Drug: Oxaliplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
384
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00156975
ADHOC
Not Provided
Not Provided
Arbeitsgruppe Lebermetastasen und Tumoren
Not Provided
Principal Investigator: Wolf O. Bechstein, Prof. Dr. Arbeitsgruppe Lebermetastasen und Tumoren
Arbeitsgruppe Lebermetastasen und Tumoren
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP