Clinical trial · Observational
An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)
A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer
NCT01039506CI-TRIAL-00038821completedClinicalTrials.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)
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic 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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPT-11 based regimens | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- UGT1A1 genotyped patients
- description
- UGT1A1 genotyped patients receive CPT-11 based regimens
- interventionNames
- Drug: CPT-11 based regimens
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- Within 3 years
- description
- Percentage of participants alive without disease progression
Secondary outcomes (5)
- measure
- Overall survival
- timeFrame
- At 3 years
- description
- Percentage of participants alive at end of study
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Metastatic colorectal cancer (adenocarcinoma) * UGT1A1 genotyped patients * Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents) Exclusion Criteria: * Contraindication of CPT-11 * Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4 * Patients to receiving CPT-11 as adjuvant chemotherapy * History of pelvic irradiation
References
Publications (0)
Data not yet available
No reference posted for this study.