Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI
Not Applicable
Completed
- Conditions
- Colorectal Cancer
- Interventions
- Genetic: UGT1A1 genotyping (TA6/TA6)Genetic: UGT1A1 genotyping (TA6/TA7)Genetic: UGT1A1 genotyping (TA7/TA7)
- Registration Number
- NCT03698253
- Brief Summary
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.
- Detailed Description
Primary objective:
Progression-free survival
Secondary objecive:
Overall survival, best objective response, disease control rate and adverse events
Number of Subjects: 41 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.
Plan of the Study:
1. This is a retrospective study.
2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
3. Duration of Treatment: Treatment was administered until disease progressed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Regorafenib plus FOLFIRI UGT1A1 genotyping (TA6/TA6) 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. Regorafenib plus FOLFIRI UGT1A1 genotyping (TA6/TA7) 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. Regorafenib plus FOLFIRI UGT1A1 genotyping (TA7/TA7) 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. Regorafenib plus FOLFIRI Regorafenib 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.
- Primary Outcome Measures
Name Time Method Progression-free survival From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months Time from treatment to disease progresses
- Secondary Outcome Measures
Name Time Method Overall survival From date of initiation of treatment until the date of death from any cause, assessed up to 23 months Time from treatment to death of subjectives
Best objective response From date of initiation of treatment until the date of disease progression, assessed up to 23 months best response recorded during treatment
Disease control rate From date of initiation of treatment until the date of disease progression, assessed up to 23 months Rate of best objective response, including complete response, partial response and stabel disease
Rate of treatment-associated adverse events. Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months. Common Terminology Criteria for Adverse Events version 3.0 was used for evaluating treatment-associated adverse events.
Trial Locations
- Locations (1)
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
🇨🇳Kaohsiung, Taiwan