Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

Kaohsiung Medical University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Genetic: UGT1A1 genotyping (TA6/TA7); Genetic: UGT1A1 genotyping (TA6/TA6); Drug: Regorafenib; Genetic: UGT1A1 genotyping (TA7/TA7)

Study type: Interventional

Funder types: Other

Identifiers

NCT03698253

KMUHIRB-E(I)-20180270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Regorafenib plus FOLFIRI

Experimental group

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.

Treatment:

Genetic: UGT1A1 genotyping (TA6/TA7)

Genetic: UGT1A1 genotyping (TA7/TA7)

Drug: Regorafenib

Genetic: UGT1A1 genotyping (TA6/TA6)