IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast (CK-PBI)
This study has been withdrawn prior to enrollment.
(PI left institution)
Sponsor:
Georgetown University
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00529334
First received: September 12, 2007
Last updated: November 19, 2013
Last verified: November 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
| Breast Cancer | Radiation: CyberKnife Partial Breast Irradiation |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast for Women With Stage 0, 1, or IIA (<=3cm) Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Georgetown University:
Primary Outcome Measures:
- 1. To evaluate the feasibility of CyberKnife body radiosurgery as the sole radiation therapy for this patient population 2. To evaluate the complication rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population [ Time Frame: 1 year ]
Secondary Outcome Measures:
- 1. To evaluate the local control rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population. 2. To evaluate Quality of Life after CyberKnife body radiosurgery PBI. [ Time Frame: 1 - 5 years ]
| Enrollment: | 0 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
CyberKnife Partial Breast Irradiation (PBI)
|
Radiation: CyberKnife Partial Breast Irradiation
Body radiosurgery will be delivered to the lumpectomy cavity with specified margin. Radiation dose will be 600 cGy x 5 stages = 3000 cGy over five to ten total days.
|
Eligibility| Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- DCIS or infiltrating ductal carcinoma of the breast <= 3cm
- margins clear by at least 2 mm
- age >=45 years
Exclusion Criteria:
- invasive lobular carcinoma
- multicentric disease
- nodal metastases
- breast implants
- pregnancy
- connective tissue disease
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529334
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529334
Locations
| United States, District of Columbia | |
| Georgtown University Medical Center | |
| Washington, District of Columbia, United States, 20057 | |
Sponsors and Collaborators
Georgetown University
Investigators
| Principal Investigator: | Jefferson EC Moulds, MD | Georgetown University |
More Information
| ClinicalTrials.gov Identifier: | NCT00529334 History of Changes |
| Other Study ID Numbers: |
GUMC 2007-153 |
| Study First Received: | September 12, 2007 |
| Last Updated: | November 19, 2013 |
Keywords provided by Georgetown University:
|
Breast Cancer Partial breast irradiation Radiosurgery |
CyberKnife Radiotherapy PBI |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on September 21, 2017