Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003324
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery
Status:
COMPLETED
Status Verified Date:
2012-07
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 in a single high dose Combining radiation therapy with surgery may be a more effective treatment for brain metastases
PURPOSE Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases
PURPOSE Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases
Detailed Description:
OBJECTIVES
Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation
Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases
Assess survival physical and cognitive functioning and quality of life of patients treated on this protocol
OUTLINE Quality of life is assessed using the FACT-BR scale physical function is assessed using the FIM scale and cognition is assessed using two brief pencil and paper tests
Patients receive focal therapy for cerebral metastases by any combination of 1 surgery plus fractionated stereotactic radiotherapy to surgical bed or 2 single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer
Patients are followed at 2 and 10 weeks then every 3 months for 18 months then every 6 months for 3 years then annually Quality of life is assessed at each followup visit
Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases no more than 6 lesions over consecutive scans and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100 Otherwise relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids and may also receive stereotactic boost to the new lesions Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids Patients are followed as above
PROJECTED ACCRUAL At least 60 patients will be enrolled in this study
Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation
Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases
Assess survival physical and cognitive functioning and quality of life of patients treated on this protocol
OUTLINE Quality of life is assessed using the FACT-BR scale physical function is assessed using the FIM scale and cognition is assessed using two brief pencil and paper tests
Patients receive focal therapy for cerebral metastases by any combination of 1 surgery plus fractionated stereotactic radiotherapy to surgical bed or 2 single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer
Patients are followed at 2 and 10 weeks then every 3 months for 18 months then every 6 months for 3 years then annually Quality of life is assessed at each followup visit
Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases no more than 6 lesions over consecutive scans and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100 Otherwise relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids and may also receive stereotactic boost to the new lesions Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids Patients are followed as above
PROJECTED ACCRUAL At least 60 patients will be enrolled in 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 |
|---|---|---|---|
| NCI-G98-1417 | None | None | None |
| UCLA-HSPC-9710074 | None | None | None |
| UCLA-HSPC-971007401 | None | None | None |