Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002583
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
1999-11-01
Brief Title:
Vinorelbine Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Prospective Randomized Study of Adjuvant Chemotherapy With Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer With Companion Tumour Marker Evaluation
Status:
COMPLETED
Status Verified Date:
2020-04
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 combination chemotherapy is more effective than no further treatment for non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of vinorelbine plus cisplatin with that of no further therapy in treating patients who have stage I or stage II non-small cell lung cancer that has been completely removed during surgery
PURPOSE Randomized phase III trial to compare the effectiveness of vinorelbine plus cisplatin with that of no further therapy in treating patients who have stage I or stage II non-small cell lung cancer that has been completely removed during surgery
Detailed Description:
OBJECTIVES I Compare the duration of overall and disease-free survival in patients with completely resected non-small cell lung cancer NSCLC randomized to adjuvant chemotherapy with vinorelbine and cisplatin versus observation only II Confirm the prognostic significance of ras mutations when present in the primary tumor III Provide a comprehensive tumor bank linked to a clinical database for the further study of molecular markers in resected NSCLC IV Measure and compare the health-related quality of life of patients on both treatment arms V Evaluate any toxicity related to this treatment regimen
OUTLINE This is a randomized study Patients are stratified according to participating institution nodal status N0 vs N1 and ras mutation status of primary tumor absent vs present vs unknown Patients are randomized to one of two treatment arms Arm I Patients are evaluated at 3 and 6 months after randomization Arm II Patients receive vinorelbine IV over 6-10 minutes weekly for 16 weeks Patients also receive cisplatin IV on days 1 and 8 every 4 weeks for a total of 4 courses Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at Canadian centers Quality of life assessments are optional for ECOG and SWOG centers Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study within 675 years
OUTLINE This is a randomized study Patients are stratified according to participating institution nodal status N0 vs N1 and ras mutation status of primary tumor absent vs present vs unknown Patients are randomized to one of two treatment arms Arm I Patients are evaluated at 3 and 6 months after randomization Arm II Patients receive vinorelbine IV over 6-10 minutes weekly for 16 weeks Patients also receive cisplatin IV on days 1 and 8 every 4 weeks for a total of 4 courses Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at Canadian centers Quality of life assessments are optional for ECOG and SWOG centers Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study within 675 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-BR10 | OTHER | None | None |
| CLB-9795 | OTHER | None | None |
| E-JBR10 | OTHER | None | None |
| SWOG-JBR10 | OTHER | None | None |
| GW-565040 | None | None | None |
| NCI-V94-0492 | OTHER_GRANT | None | None |
| CDR0000063698 | OTHER | PDQ | None |