Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002852
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
Status:
COMPLETED
Status Verified Date:
2013-07
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:
Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer 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 surgery is more effective with or without chemotherapy for non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who following complete surgical resection of their disease are defined as high risk based on the presence of a T2N0 tumor according to the criteria of the International Staging System for lung cancer
SECONDARY OBJECTIVES
I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy
II To determine the toxicities associated with adjuvant chemotherapy III To describe the pattern of disease recurrence
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor histology squamous cell vs nonsquamous cell degree of differentiation poorly differentiated vs other and mediastinal node sampling at surgery yes vs no Within 4-8 weeks after surgery patients are randomized to 1 of 2 treatment arms
Arm IPatients receive no further therapy
Arm II Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1 Treatment continues every 3 weeks for 4 courses
Patients are followed every 4 months for 2 years and then every 6 months thereafter
I To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who following complete surgical resection of their disease are defined as high risk based on the presence of a T2N0 tumor according to the criteria of the International Staging System for lung cancer
SECONDARY OBJECTIVES
I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy
II To determine the toxicities associated with adjuvant chemotherapy III To describe the pattern of disease recurrence
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor histology squamous cell vs nonsquamous cell degree of differentiation poorly differentiated vs other and mediastinal node sampling at surgery yes vs no Within 4-8 weeks after surgery patients are randomized to 1 of 2 treatment arms
Arm IPatients receive no further therapy
Arm II Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1 Treatment continues every 3 weeks for 4 courses
Patients are followed every 4 months for 2 years and then every 6 months thereafter
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-9633 | None | None | None |
| CDR0000065095 | None | None | None |
| CLB-C9633 | None | None | None |