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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00156975
• Other study ID #: ADHOC
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: December 24, 2009
• Start date: November 2004

Study information

• Verified date: April 2007
• Source: Arbeitsgruppe Lebermetastasen und Tumoren
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 384
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Capecitabine

• Oxaliplatin

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik	Dresden	Sachsen
Germany	Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II	Essen
Germany	Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität	Frankfurt Am Main

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgruppe Lebermetastasen und Tumoren

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcomes:
Primary	Disease free survival
Secondary	Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity