Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002823
Status:
COMPLETED
Last Update Posted:
2013-03-28
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER
Status:
COMPLETED
Status Verified Date:
2011-04
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 given after surgery is more effective than surgery alone for non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy following surgery with that of surgery alone in treating patients who have stage I stage II or stage IIIA non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy following surgery with that of surgery alone in treating patients who have stage I stage II or stage IIIA non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the impact on overall survival of adjuvant cisplatin and either a vinca alkaloid or etoposide with or without radiotherapy vs no adjuvant chemotherapy in patients with completely resected stage IIIIII non-small cell lung cancer II Assess the frequency of treatment-related deaths and severe toxic effects III Describe the patterns of failure second malignancies and toxic effects associated with each treatment regimen
OUTLINE This is a randomized multicenter study Patients are stratified by participating institution type of prior surgery and pathologic stage Each participating center will determine which combination chemotherapy regimen and which of three cisplatin doses will be given to all patients treated at that center The treatment group receives cisplatin combined with either vindesine vinblastine vinorelbine or etoposide every 3-4 weeks for 3-4 courses depending on the dose of cisplatin The second group receives no adjuvant chemotherapy Treating institutions determine prior to entering the trial which patients receive adjuvant radiotherapy none those with node-positive disease those with N1 disease only those with N2 disease only or those eligible for a randomized radiotherapy trial For patients in the treatment group radiotherapy begins 3-4 weeks after the last course Patients are followed at 6 months then annually
PROJECTED ACCRUAL A maximum of 3300 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified by participating institution type of prior surgery and pathologic stage Each participating center will determine which combination chemotherapy regimen and which of three cisplatin doses will be given to all patients treated at that center The treatment group receives cisplatin combined with either vindesine vinblastine vinorelbine or etoposide every 3-4 weeks for 3-4 courses depending on the dose of cisplatin The second group receives no adjuvant chemotherapy Treating institutions determine prior to entering the trial which patients receive adjuvant radiotherapy none those with node-positive disease those with N1 disease only those with N2 disease only or those eligible for a randomized radiotherapy trial For patients in the treatment group radiotherapy begins 3-4 weeks after the last course Patients are followed at 6 months then annually
PROJECTED ACCRUAL A maximum of 3300 patients will be accrued for this study
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-96010 | None | None | None |
| FRE-IALT | None | None | None |