Clinical trial · Interventional
High-dose FOLFIRI in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28
High-dose FOLFIRI Versus Standard-dose FOLFIRI or FOLFOX-6 in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28: A Randomized, Opened, Phase II Clinical Trial
NCT03329183CI-TRIAL-00037087unknownPhase 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)
This trial aims to evaluate the efficacy, safety of high-dose FOLFIRI regimen in advanced colorectal cancer patients with wild-type UGT1A1\*6 and \*28.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- HD-FOLFIRI
- description
- Advanced CRC patients with Wild-type UGT1A1\*6 and \*28 receive high-dose FOLFIRI regimen (Irinotecan 260mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course.)
- interventionNames
- Drug: Irinotecan
- type
- NO_INTERVENTION
- label
- SD-FOLFIRI
- description
- Advanced CRC patients with Wild-type UGT1A1\*6 and \*28 receive standard-dose FOLFIRI regimen (Irinotecan 180mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course)
- type
- NO_INTERVENTION
- label
- SD-FOLFOX-6
- description
- Advanced CRC patients with Wild-type UGT1A1\*6 and \*28 receive standard-dose FOLFOX-6 regimen (Oxaliplatin 130mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence * Patients should be with UGT1A1\*28 wild-type TA6/6 and UGT1A1\*6 wild-type G/G * Patients have measurable lesions * Patients are not available for targeted therapy or patients refuse to receive targeted therapy * Age should be more than 18 years * Performance status should be 0-2 * Hemoglobin should be more than 9.0 g/dL; Absolute Neutrophil Count should be more than 1,500/mm3; Platelet should be more than 80,000/mm3;Total Bilirubin should be less than 1.5 times of the upper limit of normal value; Alanine aminotransferase and Glutamic-oxaloacetic transaminase should less than 2.5 times of the upper limit of normal value (it can be 5 times if liver metastasis); Creatinine should be be less than 1.5 times of the upper limit of normal value Exclusion Criteria: * Patients with UGT1A1\*28 wild-type TA6/7, TA7/7 and UGT1A1\*6 wild-type G/A,A/A; * Patients with brain metastases; * Patients could not tolerate chemotherapy; * Patients have secondary primary tumor;
References
Publications (0)
Data not yet available
No reference posted for this study.