Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006344
Status:
WITHDRAWN
Last Update Posted:
2015-05-19
First Post:
2000-10-04
Brief Title:
Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
A Randomized Phase III Dose Response Study of Prophylactic Cranial Irradiation PCI for Small Cell Carcinoma of the Lung
Status:
WITHDRAWN
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
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 It is not yet known which regimen of radiation therapy may be more effective in preventing brain metastases
PURPOSE Randomized phase III trial to study the effectiveness of radiation therapy in preventing brain metastases in patients who have small cell lung cancer that has been diagnosed within the past year
PURPOSE Randomized phase III trial to study the effectiveness of radiation therapy in preventing brain metastases in patients who have small cell lung cancer that has been diagnosed within the past year
Detailed Description:
OBJECTIVES I Compare the efficacy of low dose versus high dose prophylactic cranial irradiation in preventing brain metastases in patients with small cell carcinoma of the lung II Determine the neuropsychiatric status of these patients before and after treatment
OUTLINE This is a randomized multicenter study The right or left hemisphere of each patients brain are randomized to one of two treatment arms All patients receive whole brain radiotherapy 5 days a week over 25 weeks for a total of 12 fractions Arm I Patients receive radiotherapy to the left cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy Arm II Patients receive radiotherapy to the right cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy Patients with extensive disease may also receive thoracic radiotherapy if not administered previously Patients are followed at 1 3 6 9 and 12 months and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 16-40 patients will be accrued for this study within 1-4 years
OUTLINE This is a randomized multicenter study The right or left hemisphere of each patients brain are randomized to one of two treatment arms All patients receive whole brain radiotherapy 5 days a week over 25 weeks for a total of 12 fractions Arm I Patients receive radiotherapy to the left cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy Arm II Patients receive radiotherapy to the right cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy Patients with extensive disease may also receive thoracic radiotherapy if not administered previously Patients are followed at 1 3 6 9 and 12 months and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 16-40 patients will be accrued for this study within 1-4 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 |
|---|---|---|---|
| NCI-V00-1613 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016059 |
| P30CA016059 | NIH | None | None |
| MCV-MCC-9912-2A | None | None | None |