Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328575
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2006-05-19
Brief Title:
Using Intensity Modulated Radiation Therapy IMRT for Brain Metastases
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Phase I Dose Escalation Trial in Patients With Brain Metastases Using IMRT
Status:
COMPLETED
Status Verified Date:
2016-10
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:
The purpose of this study is to determine if using intensity modulated radiation therapy for brain metastases is safe and will improve local control more than standard whole brain radiation therapy
Detailed Description:
Traditionally whole brain radiation therapy WBRT has been the primary therapy for patients with brain metastases Despite this therapy patients still have poor survival of four to six months Untreated patients have a median survival of one month Up to one half of these patients die of causes related to the presence of brain metastases In a Phase III RTOG trial the efficacy and safety of delivering accelerated fractionation was investigated in patients with good prognostic factors No toxicity was observed with escalating dose of irradiation up 7040Gy in 16Gy twice daily treatments However in a randomized trial the use of hyperfractionation did not appear to improve survival when compared to 30Gy whole brain irradiation delivered in 10 fractions
Current therapeutic approach also includes stereotactic radiosurgery SRS Several retrospective studies have demonstrated improved local tumor control of 80 with addition of SRS to WBRT These local control rates were comparable to surgery In a recently published randomized trial by RTOG 95-08 TJU accrued 42 patients to this trial Andrews et al demonstrated improved survival in patients with solitary brain lesion treated with SRS Median survival was 65 months in patients treated with WBRT and SRS compared to 49 months in patients treated with WBRT alone Also these patients were more likely to have stable or improved performance status
Current therapeutic approach also includes stereotactic radiosurgery SRS Several retrospective studies have demonstrated improved local tumor control of 80 with addition of SRS to WBRT These local control rates were comparable to surgery In a recently published randomized trial by RTOG 95-08 TJU accrued 42 patients to this trial Andrews et al demonstrated improved survival in patients with solitary brain lesion treated with SRS Median survival was 65 months in patients treated with WBRT and SRS compared to 49 months in patients treated with WBRT alone Also these patients were more likely to have stable or improved performance status
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 |
|---|---|---|---|
| 05U443R | OTHER | IRB | None |
| 2005-70 | OTHER | None | None |