Clinical trial · Interventional
Tailored Treatment in Metastatic Colorectal Cancer
Tailored Treatment of Metastatic Colorectal Cancer Based on Genetic Markers
NCT00396487CI-TRIAL-00018244terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Only one patient included as per Feb. 4, 2008.
Summary
Brief summary (as posted)
To compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase III trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The primary end point is
- measure
- Response according to RECIST criteria.
Secondary outcomes (4)
- measure
- Secondary end points are
- measure
- Progression free survival
- measure
- Overall survival
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic colorectal cancer * Histopathological verification of the primary tumor * Measurable disease according to RESIST criteria * Single agent chemotherapy indicated * Performance status \>=2 * Age \>= 60 years * Life expectancy \> 3 months * Adequate liver and kidney function as evaluated by bilirubin \<= 3 times of normal upper limit, ALAT \<= 3 times upper normal limit (\<= 5 times upper normal limit in case of liver metastases), serum creatinine \<= 1.5 times normal upper limit. * ANC \>=1.5 x 109/l and platelets \>= 100 x 109/l * Informed consent Exclusion Criteria: * Patients with CNS metastases * Other malignant disease within the last 5 years except for non-melanoma skin cancer and carcinoma in situ of cervix uteri * Previous chemotherapy for metastatic disease * Adjuvant chemotherapy \< 6 months before inclusion * Patients with previous major toxic or allergic reaction to the protocol drugs
References
Publications (0)
Data not yet available
No reference posted for this study.