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
Currently, there is no standard second line treatment for patients with neuroendocrine carcinoma. Irinotecan monotherapy or combination regimen has shown promising in previous study. The study was designed to confirm thet FOLFIRI regimen can be used as a second-line regimen for patients with advanced or metastatic neuroendocrine carcinoma who have progressed after first-line chemotherapy with platinum based regimen.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFIRI | Experimental | Irinotecan:180mg/m2 ,iv drip for 90min d1, 5-FU 2400mg/m2, iv drip for 46h, 5-FU 400mg/m2 iv d1, CF 200mg/m2 iv drip for 2h d1, q2W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFIRI Protocol | Drug | Irinotecan:180mg/m2 ,iv drip for 90min d1, 5-FU 2400mg/m2, iv drip for 46h, 5-FU 400mg/m2 iv d1, CF 200mg/m2 iv drip for 2h d1, q2W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation by RECIST 1.1 | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause | baseline, every 8 weeks up to 1 year after last patient first treatment |
| Overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen | Contact | 86-10-88196561 | linshenpku@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C480833 | IFL protocol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Overall survival is defined as the time from date of start of treatment to date of death due to any cause |
| baseline, every 8 weeks up to 1 year after last patient first treatment |
| Incidence of Treatment-related Adverse Events (Safety and Tolerability) | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |