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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, Taiwan
Progression-free survival
Time from treatment to disease progresses
Time frame: From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months
Overall survival
Time from treatment to death of subjectives
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months.
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The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2