Single Dose Partial Breast Radiotherapy (RSU)

Duke University

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Radiation: Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00944528

Pro00015617

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast
• Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
• Clinical T1N0M0
• 55 years of age or older
• Estrogen receptor (ER) positive,
• No evidence of lymphovascular space invasion on initial biopsy
• Not pregnant. If not post-menopausal must adhere to birth control measures
• White blood cell count > 3000, Hemoglobin > 9, platelets >100000
• Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min

Exclusion criteria

• Neoadjuvant chemotherapy
• Breast implants
• Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
• Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
• HER-2/neu positive
• Positive serum pregnancy test

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

Single dose radiosurgery: Dose Level 1

Experimental group

Description:

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

Treatment:

Radiation: Radiosurgery

Single dose radiosurgery: Dose Level 2

Experimental group

Description:

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

Treatment:

Radiation: Radiosurgery

Single dose radiosurgery: Dose Level 3

Experimental group

Description:

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

Treatment:

Radiation: Radiosurgery