Ignite Creation Date:
2024-05-06 @ 7:43 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02582931
Status:
COMPLETED
Last Update Posted:
2019-01-17
First Post:
2015-10-20
Brief Title:
MRI-Guided Stereotactic Body Radiation Therapy SBRT for Ovarian Cancer
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Pilot Study of MRI-Guided Stereotactic Body Radiation Therapy SBRT for Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2019-01
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 investigators propose to evaluate the feasibility safety and preliminary efficacy of delivering online adaptive magnetic resonance imaging MRI-guided and gated stereotactic body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel integrated Co-60 MRI treatment machine To best assess this technology the investigators will focus on patients that have no more than three sites of progressive disease within the central thorax liver andor non-liver abdominopelvis to receive adaptive MRI-guided and gated SBRT with MRI simulation Patients will be treated in five fractions over one to two weeks By adhering to strict normal tissue constraints expected toxicity will be within the current standard of care but will allow adaptation based on daily anatomic changes The prescription dose will be determined based on hard normal tissue constraints and capped at 10Gy per fraction Although the long term goal will be to achieve improved local control and disease-free survival with reduced toxicity the present study will be driven by the short term goal of demonstrating the feasibility of this novel treatment approach for recurrent or metastatic ovarian cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None