Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-02 @ 10:07 PM
Study NCT ID:
NCT03769935
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance Therapy for Small-cell Lung Cancer
Sponsor:
Qingdao Central Hospital
Organization:
Study Overview
Official Title:
Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The primary endpoint is progression free survival and second endpoints are toxicities, overall survival.
Detailed Description:
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy could prolong progression free survival.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: