Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00955695|
Recruitment Status : Unknown
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was: Not yet recruiting
First Posted : August 10, 2009
Last Update Posted : August 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: erlotinib hydrochloride Drug: gefitinib Other: questionnaire administration Procedure: quality-of-life assessment Radiation: whole-brain radiation therapy||Phase 3|
- Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||242 participants|
|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|
|Study Start Date :||May 2009|
- Time to symptomatic brain metastases
- Progression-free survival
- Overall survival
- Safety and tolerability of prophylactic cranial radiotherapy
- Psycho-neurological effects of prophylactic cranial radiotherapy
- Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955695
|Principal Investigator:||Chang Geol Lee, MD||Yonsei University|