Clinical trial · Interventional
Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients
Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen
NCT01271582CI-TRIAL-00036801unknownPhase 4ClinicalTrials.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 investigate the association between UGT1A1 polymorphisms and neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer treated with FOLFIRI regimen.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stage IV Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan, 5FU, leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRI
- description
- Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study)
- interventionNames
- Drug: Irinotecan, 5FU, leucovorin
Primary outcomes (1)
- measure
- Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment
- timeFrame
- 2 weeks
- description
- During the first cycle of treatment
Secondary outcomes (3)
- measure
- Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration
- timeFrame
- 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:Subjects should meet all of the following criteria to participate in the trial. * Histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy * Subjects who are expected to receive toxicity test at least once after FOLFIRI treatment. * Aged 18 years or older. * ECOG performance status of ≤ 2. * Anticipated life expectancy of ≥ 3 months. * Clinically acceptable function of bone marrow, kidney and liver function as below. 1. ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3 2. Serum total bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present) 3. Serum creatinine ≤ 1.5 mg/dL or CLcr \> 60 ml/min * Subjects whose written informed consent can be obtained prior to their participation in the trial. Exclusion Criteria: Subjects who meet any of the following criteria should not be included in the trial. * Pregnant or breast feeding women * Serious concurrent complication, severe active infection. * Subjects with chronic diarrhea, paralytic ileums, pulmonary fibrosis or pneumonia interstitialis * Subjects with epilepsia or severe psychiatric disorders. * Subjects who are regarded to be unsuitable for this trial by the investigator. * Subjects who are participating in other clinical trials * Subjects who have received prior chemotherapy including irinotecan.
References
Publications (0)
Data not yet available
No reference posted for this study.