Clinical trial · Interventional
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
NCT00156975CI-TRIAL-00002942unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Primary outcomes:
- measure
- Disease free survival
Secondary outcomes (1)
- measure
- Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.