A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast

NCT00529334 | Withdrawn DMC

• 1 other identifier: GUMC 2007-153
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Partial breast irradiation; Radiosurgery; CyberKnife; Radiotherapy; PBI

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• 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.

  1 - 5 years

Study Arms (1)

1

EXPERIMENTAL

CyberKnife Partial Breast Irradiation (PBI)

Radiation: CyberKnife Partial Breast Irradiation

Interventions

CyberKnife Partial Breast Irradiation RADIATION

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.

1

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DCIS or infiltrating ductal carcinoma of the breast \<= 3cm
• margins clear by at least 2 mm
• age \>=45 years

You may not qualify if:

• invasive lobular carcinoma
• multicentric disease
• nodal metastases
• breast implants
• pregnancy
• connective tissue disease

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgtown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jefferson EC Moulds, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

US (1)