Single Dose Partial Breast Radiotherapy

NCT ID: NCT00944528

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-28
• Study Completion Date: 2023-03-25

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single dose radiosurgery: Dose Level 1

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

Group Type: EXPERIMENTAL

Radiosurgery

Intervention Type: RADIATION

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

Single dose radiosurgery: Dose Level 2

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

Group Type: EXPERIMENTAL

Radiosurgery

Intervention Type: RADIATION

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

Single dose radiosurgery: Dose Level 3

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

Group Type: EXPERIMENTAL

Radiosurgery

Intervention Type: RADIATION

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

Interventions

Radiosurgery

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

Intervention Type: RADIATION

Other Intervention Names

External beam radiation therapy

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Blitzblau, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Dept of Radiation Oncology

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Nattinger AB, Hoffmann RG, Kneusel RT, Schapira MM. Relation between appropriateness of primary therapy for early-stage breast carcinoma and increased use of breast-conserving surgery. Lancet. 2000 Sep 30;356(9236):1148-53. doi: 10.1016/S0140-6736(00)02757-4.

Reference Type: BACKGROUND

PMID: 11030294 (View on PubMed)

Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.

Reference Type: BACKGROUND

PMID: 19395195 (View on PubMed)

Luini A, Orecchia R, Gatti G, Intra M, Ciocca M, Galimberti V, Veronesi P, Santos GR, Gilardi D, Veronesi U. The pilot trial on intraoperative radiotherapy with electrons (ELIOT): update on the results. Breast Cancer Res Treat. 2005 Sep;93(1):55-9. doi: 10.1007/s10549-005-3782-1.

Reference Type: BACKGROUND

PMID: 16184459 (View on PubMed)

Horton JK, Siamakpour-Reihani S, Lee CT, Zhou Y, Chen W, Geradts J, Fels DR, Hoang P, Ashcraft KA, Groth J, Kung HN, Dewhirst MW, Chi JT. FAS Death Receptor: A Breast Cancer Subtype-Specific Radiation Response Biomarker and Potential Therapeutic Target. Radiat Res. 2015 Nov;184(5):456-69. doi: 10.1667/RR14089.1. Epub 2015 Oct 21.

Reference Type: DERIVED

PMID: 26488758 (View on PubMed)

Other Identifiers

Pro00015617

Identifier Type: -

Identifier Source: org_study_id