Clinical trial · Interventional
Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI
Prognostic Value of EGFR Expression, KRAS Mutation and Tumor Sideness in Patients With Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI as a Third- or Fourth-line Setting
NCT03698253CI-TRIAL-00035161completedN/AClinicalTrials.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 survey is a retrospective study to evaluate the prognotic value of EGFR expression, KRAS mutations and tumor sideness in patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib | Drug | Regorafenib | ALIAS |
| UGT1A1 genotyping (TA6/TA6) | Genetic | — | UNRESOLVED |
| UGT1A1 genotyping (TA6/TA7) | Genetic | — | UNRESOLVED |
| UGT1A1 genotyping (TA7/TA7) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Regorafenib plus FOLFIRI
- description
- Regimen for treatment consists of irinotecan (180 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7); 120 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA7/TA7)), followedby Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks. After every 2 cycles of each different dose of irinotecan, if adverse events (AEs) are under the grade 2, we will escalate the dose of 30 mg/m2. The estimated maximal dose of irinotecan is 260 mg/m2 for UGT1A1 genotyping (TA6/TA6); 240 mg/m2 for UGT1A1 genotyping (TA6/TA7); 180 mg/m2 for UGT1A1 genotyping (TA7/TA7). Regorafenib is administered at adjusted doseage of 120 mg daily for 3 weeks in a 4-week cycle.
- interventionNames
- Drug: Regorafenib
- Genetic: UGT1A1 genotyping (TA6/TA6)
- Genetic: UGT1A1 genotyping (TA6/TA7)
- Genetic: UGT1A1 genotyping (TA7/TA7)
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 20-85 years old * Histologically proven metastatic colorectal cancer (mCRC). * Patients with progressing mCRC who were previously treated with FOLFOX, FOLFIRI, anti-VGFR monoclonal antibody (MoAb), and anti-EGFR MoAb if KRAS-wild-type tumors were identified. * Patient was able to understand the requirements of the study and written informed consent was obtained from each subject. Exclusion Criteria: * Patients who do not meet the including criteria or unwilling to participate
References
Publications (0)
Data not yet available
No reference posted for this study.