Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
Study NCT ID:
NCT00955695
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2009-08-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
National Cancer Center, Korea
Organization:
Study Overview
Official Title:
A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Nonprogressive on Gefitinib or Erlotinib
Status:
UNKNOWN
Status Verified Date:
2010-01
Last Known Status:
NOT_YET_RECRUITING
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: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
Secondary
* Determine the progression-free survival in patients treated with this regimen.
* Determine the overall survival in patients treated with this regimen.
* Determine the safety and tolerability of this regimen in these patients.
* Determine the psycho-neurological effects of this regimen in these patients.
* Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.
* Group 1: Patients undergo prophylactic brain radiotherapy.
* Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically.
After completion of study therapy, patients are followed up periodically.
Primary
* Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
Secondary
* Determine the progression-free survival in patients treated with this regimen.
* Determine the overall survival in patients treated with this regimen.
* Determine the safety and tolerability of this regimen in these patients.
* Determine the psycho-neurological effects of this regimen in these patients.
* Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.
* Group 1: Patients undergo prophylactic brain radiotherapy.
* Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically.
After completion of study therapy, patients are followed up periodically.
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDR0000639096 | REGISTRY | PDQ (Physician Data Query) | View |