Colorectal Cancer
Conditions
Keywords
EGFR, KRAS, tumor sideness, FOLFIRI, regorafenib, metastatic colorectal cancer
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.
Interventions
DRUGRegorafenib
Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle
GENETICUGT1A1 genotyping (TA6/TA6)
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2
GENETICUGT1A1 genotyping (TA6/TA7)
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2
GENETICUGT1A1 genotyping (TA7/TA7)
The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months | Time from treatment to disease progresses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From date of initiation of treatment until the date of death from any cause, assessed up to 23 months | Time from treatment to death of subjectives |
| Best objective response | From date of initiation of treatment until the date of disease progression, assessed up to 23 months | best response recorded during treatment |
| Disease control rate | From date of initiation of treatment until the date of disease progression, assessed up to 23 months | Rate of best objective response, including complete response, partial response and stabel disease |
| Rate of treatment-associated adverse events. | Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months. | Common Terminology Criteria for Adverse Events version 3.0 was used for evaluating treatment-associated adverse events. |
Countries
Taiwan
Outcome results
None listed