Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698253
• Other study ID #: KMUHIRB-E(I)-20180270
• Status: Completed
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: June 1, 2018

Study information

• Verified date: October 2018
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Regorafenib
Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle

Genetic:
• 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

Locations

Country	Name	City	State
Taiwan	Chung-Ho Memorial Hospital, Kaohsiung Medical University:	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.