Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Single dose or radiation in 15Gy, 18Gy or 21Gy

Radiosurgery

Rachel Blitzblau, MD PhD

This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.

This study will assess the safety of partial breast radiosurgery as measured by the incidence of acute toxicity and wound healing complications in three dose cohorts.

Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped for evaluation and consideration of revision. If at most one DLT is observed then escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of irradiation.

Single Dose Partial Breast Radiotherapy

Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study

Pre and post-radiotherapy for exploratory analysis of radiation response

Pre and post-radiotherapy for exploratory analysis of radiation response.

As measured by the incidence of acute toxicity and wound healing complications

Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment.

EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance.

GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in the size or shape of the treated breast as compared to the opposite breast or the appearance of the breast before treatment. There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes a mild change in its shape or size.

Duke University

A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy

Single Dose Radiosurgery: Dose Level 1

A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy

Note: One participant in dose level 2 was killed in an unrelated motor vehicle accident and was not considered in all-cause mortality.

Single Dose Radiosurgery: Dose Level 2

A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy

Single Dose Radiosurgery: Dose Level 3

A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Radiosurgery: Single dose or radiation in 15Gy, 18Gy or 21Gy

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Jennifer Mewshaw, MS RN

A single dose of radiation in 15Gy (dose level 1), 18Gy (dose level 2) or 21Gy (dose level 3) given in radiosurgery technique about 10 days before lumpectomy.

Single Dose Radiosurgery: All Dose Levels

Participants receiving all dose levels (8 at 15Gy/Dose level 1, 8 at 18Gy/Dose level 2, 16 at 21Gy/Dose level 3)

Spots Global Cancer Trial Database for Single Dose Partial Breast Radiotherapy

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