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

NCT00156975 | Unknown Phase 3

• 1 other identifier: ADHOC
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Neoplasms; Liver Metastases

Keywords

Oxaliplatin; Capecitabine; Chemotherapy; Resection; Liver metastases; Liver resection; Adjuvant

Outcome Measures

Primary Outcomes (2)

• Primary outcomes:

• Disease free survival

Secondary Outcomes (1)

• Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity

Interventions

Capecitabine DRUG

Oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Arbeitsgruppe Lebermetastasen und Tumoren: lead

Study Sites (3)

Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik

Dresden, Saxony, 011307, Germany

Location

Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II

Essen, 45122, Germany

Location

Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität

Frankfurt am Main, 60590, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Wolf O. Bechstein, Prof. Dr.

  Arbeitsgruppe Lebermetastasen und Tumoren

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: November 1, 2004
• Last Updated: December 25, 2009

Record last verified: 2007-04

Locations

DE (3)