Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI
NCT ID: NCT03698253
Last Updated: 2018-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2013-10-01
2018-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Regorafenib plus FOLFIRI
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
Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle
UGT1A1 genotyping (TA6/TA6)
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2
UGT1A1 genotyping (TA6/TA7)
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2
UGT1A1 genotyping (TA7/TA7)
The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2
Interventions
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Regorafenib
Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle
UGT1A1 genotyping (TA6/TA6)
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2
UGT1A1 genotyping (TA6/TA7)
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2
UGT1A1 genotyping (TA7/TA7)
The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
85 Years
ALL
No
Sponsors
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Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Responsible Party
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Jaw-Yuan Wang, MD, PhD
Professor, Vice Superintendent
Principal Investigators
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Jaw-Yuan Wang, PhD
Role: STUDY_CHAIR
Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
Locations
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Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, , Taiwan
Countries
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Other Identifiers
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KMUHIRB-E(I)-20180270
Identifier Type: -
Identifier Source: org_study_id
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