Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091156
Status:
TERMINATED
Last Update Posted:
2012-07-16
First Post:
2004-09-07
Brief Title:
Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib Iressa Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth It is not yet known whether giving gefitinib after initial chemotherapy is effective in delaying the recurrence of non-small cell lung cancer
PURPOSE This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer
PURPOSE This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer that did not progress on prior first-line palliative induction chemotherapy when treated with adjuvant gefitinib vs placebo
Secondary
Compare progression-free survival of patients treated with these regimens
Determine the safety and toxicity of gefitinib in these patients
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to initial disease stage IIIB vs IV WHO performance status at the end of prior first-line palliative induction chemotherapy 0-1 vs 2 best patient response to prior first-line palliative induction chemotherapy objective response vs stable disease and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral gefitinib once daily
Arm II Patients receive oral placebo once daily In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 598 patients 299 per treatment arm will be accrued for this study within 85 years
Primary
Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer that did not progress on prior first-line palliative induction chemotherapy when treated with adjuvant gefitinib vs placebo
Secondary
Compare progression-free survival of patients treated with these regimens
Determine the safety and toxicity of gefitinib in these patients
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to initial disease stage IIIB vs IV WHO performance status at the end of prior first-line palliative induction chemotherapy 0-1 vs 2 best patient response to prior first-line palliative induction chemotherapy objective response vs stable disease and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral gefitinib once daily
Arm II Patients receive oral placebo once daily In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 598 patients 299 per treatment arm will be accrued for this study within 85 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 |
|---|---|---|---|
| 2004-001331-36 | EUDRACT_NUMBER | None | None |
| EORTC-08021 | None | None | None |
| ILCP-0103 | None | None | None |