Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003240
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Major Randomised Trial to Determine the Value of Cisplatin-Based Chemotherapy For All Patients With Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 It is not known whether giving chemotherapy in addition to standard therapy is a more effective treatment for lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of standard therapy given with or without combination chemotherapy in treating patients with non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of standard therapy given with or without combination chemotherapy in treating patients with non-small cell lung cancer
Detailed Description:
OBJECTIVES I Assess whether the addition of cisplatin-based chemotherapy to standard treatment improves survival in patients with non-small cell lung cancer
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms Arm I Patients undergo primary surgery radical radiotherapy radiotherapy with surgery or best supportive care Arm II Patients undergo treatment as in arm I Beginning within 10 weeks after surgery or radical radiotherapy or as soon as possible after diagnosis patients receive 1 of the following regimens Regimen A Patients receive cisplatin IV on day 1 followed by vindesine on days 1 and 8 Regimen B Patients receive mitomycin ifosfamide and cisplatin on day 1 Regimen C Patients receive mitomycin vinblastine and cisplatin on day 1 Regimen D Patients receive vinorelbine on days 1 and 8 and cisplatin on day 1 Treatment in all 4 regimens repeats every 3 weeks for 3 courses Patients are followed at 3 months 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 1800 patients will be accrued for this study within 3 years
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms Arm I Patients undergo primary surgery radical radiotherapy radiotherapy with surgery or best supportive care Arm II Patients undergo treatment as in arm I Beginning within 10 weeks after surgery or radical radiotherapy or as soon as possible after diagnosis patients receive 1 of the following regimens Regimen A Patients receive cisplatin IV on day 1 followed by vindesine on days 1 and 8 Regimen B Patients receive mitomycin ifosfamide and cisplatin on day 1 Regimen C Patients receive mitomycin vinblastine and cisplatin on day 1 Regimen D Patients receive vinorelbine on days 1 and 8 and cisplatin on day 1 Treatment in all 4 regimens repeats every 3 weeks for 3 courses Patients are followed at 3 months 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 1800 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98003 | None | None | None |
| LLCG-BLT | None | None | None |
| MRC-BLT | None | None | None |