Clinical trial · Interventional
Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer
A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer
NCT00320320CI-TRIAL-00001804terminatedPhase 2ClinicalTrials.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): Poor accrual
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.
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 |
| Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate after FOLFIRI reintroduction
Secondary outcomes (2)
- measure
- Progression-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma of colon and rectum * No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy * Advanced, metastatic or recurrent not amenable to curative local therapy * Measurable lesion(s) * ECOG performance status 0 to 2 * Normal marrow, hepatic and renal function * Provision of written informed consent Exclusion Criteria: * Active infection and/or severe comorbidity * Known history of anaphylaxis of any origin
References
Publications (0)
Data not yet available
No reference posted for this study.