Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080938
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2004-04-07
Brief Title:
Temozolomide and Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2023-06
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy Combining temozolomide with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the intracranial response rate in patients with brain metastasis secondary to non-small cell lung cancer treated with whole brain radiotherapy and temozolomide
Secondary
Determine the time to radiological progression in patients treated with this regimen
Determine the time to neurological progression confirmed by magnetic resonance imaging MRI in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients undergo whole brain radiotherapy once daily 5 days a week for 2 weeks 10 fractions Patients also receive concurrent oral temozolomide once daily on days 1-14
Beginning 3 weeks after the completion of chemoradiotherapy patients receive oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for up to 6 courses in the absence of neurologic Central Nervous System CNS progression or unacceptable toxicity
Patients were followed every 3 months for 2 years
ACCRUAL A total of 26 patients were accrued for this study
Primary
Determine the intracranial response rate in patients with brain metastasis secondary to non-small cell lung cancer treated with whole brain radiotherapy and temozolomide
Secondary
Determine the time to radiological progression in patients treated with this regimen
Determine the time to neurological progression confirmed by magnetic resonance imaging MRI in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients undergo whole brain radiotherapy once daily 5 days a week for 2 weeks 10 fractions Patients also receive concurrent oral temozolomide once daily on days 1-14
Beginning 3 weeks after the completion of chemoradiotherapy patients receive oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for up to 6 courses in the absence of neurologic Central Nervous System CNS progression or unacceptable toxicity
Patients were followed every 3 months for 2 years
ACCRUAL A total of 26 patients were 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 |
|---|---|---|---|
| E1F03 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |