Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regorafenib plus FOLFIRI | Experimental | Regimen for treatment consists of irinotecan (180 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7); 120 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA7/TA7)), followedby Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks. After every 2 cycles of each different dose of irinotecan, if adverse events (AEs) are under the grade 2, we will escalate the dose of 30 mg/m2. The estimated maximal dose of irinotecan is 260 mg/m2 for UGT1A1 genotyping (TA6/TA6); 240 mg/m2 for UGT1A1 genotyping (TA6/TA7); 180 mg/m2 for UGT1A1 genotyping (TA7/TA7). Regorafenib is administered at adjusted doseage of 120 mg daily for 3 weeks in a 4-week cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib | Drug | Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Best objective response | best response recorded during treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaw-Yuan Wang, PhD | Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ho Memorial Hospital, Kaohsiung Medical University: | Kaohsiung City | 807 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C559147 | regorafenib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| UGT1A1 genotyping (TA6/TA6) | Genetic | The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2 |
|
| UGT1A1 genotyping (TA6/TA7) | Genetic | The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2 |
|
| UGT1A1 genotyping (TA7/TA7) | Genetic | The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2 |
|
| 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 | 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. | Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |