Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 5:18 AM
Study NCT ID:
NCT00003606
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
Sponsor:
UNICANCER
Organization:
Study Overview
Official Title:
Phase III Randomized Study of Cisplatin and Etoposide With or Without Epirubicin and Cyclophosphamide for Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2021-02
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:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether combination chemotherapy with or without epirubicin and cyclophosphamide is more effective in treating patients with extensive stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without epirubicin and cyclophosphamide in treating patients who have extensive stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without epirubicin and cyclophosphamide in treating patients who have extensive stage small cell lung cancer.
Detailed Description:
OBJECTIVES: I. Compare the overall survival and survival without recurrence of patients with extensive stage small cell lung cancer after receiving cisplatin and etoposide with or without epirubicin and cyclophosphamide. II. Compare the relative dose and intensity of cisplatin and etoposide between the two groups of patients. III. Compare the complete and objective response rate and quality of life of these patients. IV. Compare the toxic effects of these 2 regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive etoposide IV on days 1 and 3 and cisplatin IV on day 2. Arm II: Patients receive etoposide and cisplatin as in arm I, plus epirubicin IV on day 1 and cyclophosphamide IV on days 1 and 3. Treatment is repeated in both arms every 28 days for up to 6 courses. Patients who achieve a partial or complete response receive cerebral and/or thoracic radiotherapy. Patients with residual tumor may receive oral etoposide for 3 of every 4 weeks. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 2.5 years.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive etoposide IV on days 1 and 3 and cisplatin IV on day 2. Arm II: Patients receive etoposide and cisplatin as in arm I, plus epirubicin IV on day 1 and cyclophosphamide IV on days 1 and 3. Treatment is repeated in both arms every 28 days for up to 6 courses. Patients who achieve a partial or complete response receive cerebral and/or thoracic radiotherapy. Patients with residual tumor may receive oral etoposide for 3 of every 4 weeks. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 2.5 years.
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?: