Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003159
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer NSCLC of Any Stage
Status:
COMPLETED
Status Verified Date:
2005-05
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 It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer
PURPOSE This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer
PURPOSE This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy
Secondary
Compare the quality of life of patients treated with these regimens
Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens
Compare resectability rates in patients treated with these regimens
Compare time to and site of relapse in patients treated with these regimens
Determine response in patients treated with preoperative chemotherapy
Determine the adverse effects of preoperative chemotherapy in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo surgical resection no more than 4 weeks after randomization
Arm II Patients receive one of the following chemotherapy regimens immediately after randomization
Regimen 1 Patients receive mitomycin IV vinblastine IV and cisplatin IV on day 1
Regimen 2 Patients receive mitomycin IV ifosfamide IV over 3 hours and cisplatin IV over 1 hour on day 1
Regimen 3 Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8
Regimen 4 Patients receive paclitaxel IV and carboplatin IV on day 1
Regimen 5 Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1
Regimen 6 Patients receive docetaxel IV and carboplatin IV on day 1 In all regimens treatment repeats every 3 weeks for a total of 3 courses Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy
Quality of life is assessed at 6 and 12 months and then annually thereafter
Patients are followed 1 month after surgery 6 months after randomization every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 600 patients 300 per treatment arm will be accrued for this study
Primary
Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy
Secondary
Compare the quality of life of patients treated with these regimens
Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens
Compare resectability rates in patients treated with these regimens
Compare time to and site of relapse in patients treated with these regimens
Determine response in patients treated with preoperative chemotherapy
Determine the adverse effects of preoperative chemotherapy in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo surgical resection no more than 4 weeks after randomization
Arm II Patients receive one of the following chemotherapy regimens immediately after randomization
Regimen 1 Patients receive mitomycin IV vinblastine IV and cisplatin IV on day 1
Regimen 2 Patients receive mitomycin IV ifosfamide IV over 3 hours and cisplatin IV over 1 hour on day 1
Regimen 3 Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8
Regimen 4 Patients receive paclitaxel IV and carboplatin IV on day 1
Regimen 5 Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1
Regimen 6 Patients receive docetaxel IV and carboplatin IV on day 1 In all regimens treatment repeats every 3 weeks for a total of 3 courses Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy
Quality of life is assessed at 6 and 12 months and then annually thereafter
Patients are followed 1 month after surgery 6 months after randomization every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 600 patients 300 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN25582437 | None | None | None |
| MRC-LU22 | None | None | None |
| EORTC-08012 | None | None | None |
| EU-97016 | None | None | None |