Trials / Completed
CompletedNCT03698253
Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| GENETIC | UGT1A1 genotyping (TA6/TA7) | The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2 |
| GENETIC | UGT1A1 genotyping (TA7/TA7) | The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2 |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2018-10-05
- Last updated
- 2018-10-05
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03698253. Inclusion in this directory is not an endorsement.