Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 9:51 PM
Study NCT ID:
NCT00529334
Status:
WITHDRAWN
Last Update Posted:
2013-11-20
First Post:
2007-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast
Sponsor:
Georgetown University
Organization:
Study Overview
Official Title:
A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast for Women With Stage 0, 1, or IIA (<=3cm) Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CK-PBI
Brief Summary:
This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase II study. It will evaluate quality of life (QOL) issues as they relate to treatment related side effects, cosmetic result, and patient convenience.
Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.
Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: