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A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast (CK-PBI)

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyberKnife Partial Breast Irradiation
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Partial breast irradiation, Radiosurgery, CyberKnife, Radiotherapy, PBI

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Georgtown University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

CyberKnife Partial Breast Irradiation (PBI)

Outcomes

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

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.

Full Information

First Posted
September 12, 2007
Last Updated
November 19, 2013
Sponsor
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT00529334
Brief Title
A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast
Acronym
CK-PBI
Official Title
A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast for Women With Stage 0, 1, or IIA (<=3cm) Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Georgetown University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Partial breast irradiation, Radiosurgery, CyberKnife, Radiotherapy, PBI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CyberKnife Partial Breast Irradiation (PBI)
Intervention Type
Radiation
Intervention Name(s)
CyberKnife Partial Breast Irradiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jefferson EC Moulds, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgtown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast

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