Clinical trial NCT03698253: Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: EGFR
KRAS
tumor sideness
FOLFIRI
regorafenib
metastatic colorectal cancer
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months
Secondary outcomes:
measure: Overall survival
timeFrame: From date of initiation of treatment until the date of death from any cause, assessed up to 23 months
measure: Best objective response
timeFrame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
measure: Disease control rate
timeFrame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
measure: Rate of treatment-associated adverse events.
timeFrame: Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months.
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Study officials:
affiliation: Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
name: Jaw-Yuan Wang, PhD
role: STUDY_CHAIR
References: