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Single Dose Partial Breast Radiotherapy (RSU)

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiosurgery
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Cancer of Breast, Cancer of the Breast, Neoplasms, Breast, Single dose radiation, Radiotherapy, Preoperative

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Single dose radiosurgery: Dose Level 1

Single dose radiosurgery: Dose Level 2

Single dose radiosurgery: Dose Level 3

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Local Control

Full Information

First Posted
July 22, 2009
Last Updated
December 12, 2022
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00944528
Brief Title
Single Dose Partial Breast Radiotherapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 28, 2010 (Actual)
Primary Completion Date
April 4, 2016 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Cancer of Breast, Cancer of the Breast, Neoplasms, Breast, Single dose radiation, Radiotherapy, Preoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single dose radiosurgery: Dose Level 1
Arm Type
Experimental
Arm Description
A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Arm Title
Single dose radiosurgery: Dose Level 2
Arm Type
Experimental
Arm Description
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Arm Title
Single dose radiosurgery: Dose Level 3
Arm Type
Experimental
Arm Description
A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Intervention Type
Radiation
Intervention Name(s)
Radiosurgery
Other Intervention Name(s)
External beam radiation therapy
Intervention Description
Single dose or radiation in 15Gy, 18Gy or 21Gy
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Description
As measured by the incidence of acute toxicity and wound healing complications
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Cosmetic Outcome
Description
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.
Time Frame
3 years
Title
Local Control
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Acquire Tissue
Description
Pre and post-radiotherapy for exploratory analysis of radiation response
Time Frame
Pre and post SRS radiosurgery
Title
Magnetic Resonance Images(MRI)
Description
Pre and post-radiotherapy for exploratory analysis of radiation response.
Time Frame
Pre and post SRS radiosurgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Blitzblau, MD PhD
Organizational Affiliation
Duke University Medical Center, Dept of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11030294
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.
Results Reference
background
PubMed Identifier
19395195
Citation
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.
Results Reference
background
PubMed Identifier
16184459
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.
Results Reference
background
PubMed Identifier
26488758
Citation
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.
Results Reference
derived

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Single Dose Partial Breast Radiotherapy

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