Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003308
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer Melanoma or Sarcoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell Melanoma and Sarcoma
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
PURPOSE Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer melanoma or sarcoma
PURPOSE Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer melanoma or sarcoma
Detailed Description:
OBJECTIVES
Evaluate whether the delivery of stereotactic radiosurgery without conventional whole brain radiotherapy is feasible in patients with 1-3 newly diagnosed brain metastases from renal cell carcinoma melanoma or sarcoma
Determine the 3- 6- and 12-month radiographic and neurologic intracranial patterns of progression ie original lesions vs new lesions in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to maximum tumor diameter 2 cm vs greater than 2 cm to 3 cm vs greater than 3 cm to 4 cm
Patients undergo stereotactic radiosurgery at an assigned dose according to tumor diameter Patients undergo MRI or CT scan at 3 6 and 12 months after treatment or until disease progression
All other therapies are allowed after stereotactic radiosurgery except external beam whole brain radiotherapy or resection of brain metastases unless there is documented progression or unrelenting mass effect that necessitates craniotomy
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 72 months
Evaluate whether the delivery of stereotactic radiosurgery without conventional whole brain radiotherapy is feasible in patients with 1-3 newly diagnosed brain metastases from renal cell carcinoma melanoma or sarcoma
Determine the 3- 6- and 12-month radiographic and neurologic intracranial patterns of progression ie original lesions vs new lesions in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to maximum tumor diameter 2 cm vs greater than 2 cm to 3 cm vs greater than 3 cm to 4 cm
Patients undergo stereotactic radiosurgery at an assigned dose according to tumor diameter Patients undergo MRI or CT scan at 3 6 and 12 months after treatment or until disease progression
All other therapies are allowed after stereotactic radiosurgery except external beam whole brain radiotherapy or resection of brain metastases unless there is documented progression or unrelenting mass effect that necessitates craniotomy
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 72 months
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E-6397 | None | None | None |