Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

Study Overview
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Brief Summary
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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
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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: This is a retrospective study. 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. Duration of Treatment: Treatment was administered until disease progressed.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Regorafenib
* Genetic: UGT1A1 genotyping (TA6/TA6)
* Genetic: UGT1A1 genotyping (TA6/TA7)
* Genetic: UGT1A1 genotyping (TA7/TA7)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regorafenib plus FOLFIRI<br>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. | Drug: Regorafenib<br>* Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle<br>* Other names: stivarga;Genetic: UGT1A1 genotyping (TA6/TA6)<br>* The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2<br>Genetic: UGT1A1 genotyping (TA6/TA7)<br>* The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2<br>Genetic: UGT1A1 genotyping (TA7/TA7)<br>* The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time from treatment to disease progresses | From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from treatment to death of subjectives | From date of initiation of treatment until the date of death from any cause, assessed up to 23 months | 
| Best objective response | best response recorded during treatment | From date of initiation of treatment until the date of disease progression, assessed up to 23 months | 
| Disease control rate | Rate of best objective response, including complete response, partial response and stabel disease | From date of initiation of treatment until the date of disease progression, assessed up to 23 months | 
| Rate of treatment-associated adverse events. | Common Terminology Criteria for Adverse Events version 3.0 was used for evaluating treatment-associated adverse events. | Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFR, KRAS, tumor sideness, FOLFIRI, regorafenib, metastatic colorectal cancer