Clinical trial · Interventional
High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
NCT00286000CI-TRIAL-00001069completedPhase 2ClinicalTrials.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)
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer
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 |
|---|---|---|---|
| Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of high dose simplified folfiri | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (3)
- measure
- Resectability
- measure
- Safety
- measure
- TTP
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven adenocarcinoma of the colon or rectum * Documented progressive metastatic disease * Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST) * WHO performance status of 0 or 1 * Adequate laboratory values of haematology, liverfunction and renal function * No previous chemotherapy for metastatic colorectal cancer Exclusion Criteria: * Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years. * Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis. * Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion. * Active uncontrolled infection * Other concomitant anticancer agent
References
Publications (0)
Data not yet available
No reference posted for this study.