Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04486755
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2020-07-15
Brief Title:
Hypofractionated Accelerated Pelvic Nodal Radiotherapy GCC 2048
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase I Dose Escalation Study of Hypofractionated Accelerated Pelvic Nodal Radiotherapy Delivered With A Simultaneously Integrated Prostate Boost For Patients With Localized Intermediate- And High-Risk Prostate Cancer GCC 2048
Status:
RECRUITING
Status Verified Date:
2024-05
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:
A phase I trial to determine the safety of delivering three sequentially shorter RT schedules 20 16 and 12 fractions of HypoFx pelvic nodal RT in combination with a HypoFx simultaneous integrated boost SIB to the prostate that have been designed to incrementally increased the biological equivalent dose BED to prostate cancer while maintaining a constant BED to normal tissue toxicity
Detailed Description:
Outcomes for patients with unfavorable intermediate-risk and high-risk prostate cancer PC have been historically poor and are now known to require multimodality treatment A standard non-surgical treatment option for patients with localized intermediate and high-risk PC is radiation therapy RT in combination with short- or long-term androgen deprivation therapy ADT
The benefit of pelvic nodal RT in this setting is unclear previous studies have been equivocal There is a growing body of evidence to demonstrate that use of hypofractionated HypoFx RT may be a safe method for increasing the dose of RT while also decreasing normal tissue toxicity
The benefit of pelvic nodal RT in this setting is unclear previous studies have been equivocal There is a growing body of evidence to demonstrate that use of hypofractionated HypoFx RT may be a safe method for increasing the dose of RT while also decreasing normal tissue toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None