Single Dose Partial Breast Radiotherapy

Breast Cancer Clinical Trial

— RSU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944528
• Other study ID #: Pro00015617
• Status: Completed
• Phase: Phase 1
• Start date: July 28, 2010
• Est. completion date: March 25, 2023

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 25, 2023
• Est. primary completion date: April 4, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acquire Tissue	Pre and post-radiotherapy for exploratory analysis of radiation response	Pre and post SRS radiosurgery
Other	Magnetic Resonance Images(MRI)	Pre and post-radiotherapy for exploratory analysis of radiation response.	Pre and post SRS radiosurgery
Primary	Maximum Tolerated Dose	As measured by the incidence of acute toxicity and wound healing complications	30 days
Secondary	Cosmetic Outcome	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.	3 years
Secondary	Local Control		3 years