Back to results

RAD 1802: Pilot Trial of Dose Adapted Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

1-3 Fraction Stereotactic Body Radiation Therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring SBRT, Breast cancer, Early stage, Radiation therapy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed.
Age>50.
Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS.
Estrogen receptor (ER) positive (>10%).
Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm.
Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative.
Zubrod Performance Status 0-2.

Exclusion Criteria:

Multifocal or multicentric cancer.
Reception of neoadjuvant chemotherapy.
Pure invasive lobular histology.
Surgical margins<2mm.
Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
Measured maximum PTV of >124cc.
Lumpectomy cavity within 5mm of body contour.

Sites / Locations

University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1-3 Fraction Breast Stereotactic Body Radiation Therapy

Arm Description

This study will enroll patients that have a confirmed histology of early stage breast cancer. The patient will undergo a lumpectomy and will then receive partial breast 1-3 fractions stereotactic body radiation therapy at a dose of 18 gy or 9 gy (depending on amount chosen) for treatment. Patients will be followed for 36 total months with specific follow-ups at 3, 6, 9, 12, 18, 24, and 36 months.

Outcomes

Primary Outcome Measures

Toxicity levels of 1-3 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0

To determine the safety of 1-3 fractions SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study.

Secondary Outcome Measures

Toxicity of breast SBRT using CTCAE v4.0

To define the acute (<90 days) and late toxicity (>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy.

Cosmetic outcome post-SBRT

To determine patient and nurse assessed cosmetic outcome at 1, 6, 12, 18, 24, and 36 months post SBRT. Patient will give a verbal satisfaction rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor of their cosmetic appearance post-SBRT. Nurse will also give their overall rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor based off of their examination of the cosmetic appearance post-SBRT.

Full Information

NCT ID

NCT03643861

First Posted

August 17, 2018

Last Updated

January 23, 2023

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03643861

Brief Title

RAD 1802: Pilot Trial of Dose Adapted Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Official Title

RAD 1802: A Pilot Trial of Dose Adapted Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 20, 2019 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study offers 1-3 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

Detailed Description

This study offers 1-3 fractions stereotactic body radiotherapy for early stage breast cancer after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility of delivering only 1-3 higher doses of radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

SBRT, Breast cancer, Early stage, Radiation therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1-3 Fraction Breast Stereotactic Body Radiation Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

1-3 Fraction Stereotactic Body Radiation Therapy

Intervention Description

Stereotactic body radiation therapy (SBRT) has gained favor in the treatment of select central nervous system, lung, and abdominal malignancies due to its ability to deliver highly conformal doses of radiotherapy while using sharp dose gradients to deliver comparatively lower doses to the surrounding normal tissue. Utilization of SBRT is more labor intensive than conventional fractionation and requires precise immobilization and localization techniques with daily image guidance with direct physician and physicist oversight for all treatments. While more labor intensive and often utilizing more advanced technologies, SBRT allows the advantage of reducing setup margins compared to conventionally fractionated treatment while being able to shorten overall treatment times due to the ability to safely dose escalate high risk areas

Primary Outcome Measure Information:

Title

Toxicity levels of 1-3 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0

Description

Time Frame

0-2 years

Secondary Outcome Measure Information:

Title

Toxicity of breast SBRT using CTCAE v4.0

Description

To define the acute (<90 days) and late toxicity (>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy.

Time Frame

0-2 years

Title

Cosmetic outcome post-SBRT

Description

Time Frame

0-2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed. Age>50. Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS. Estrogen receptor (ER) positive (>10%). Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm. Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative. Zubrod Performance Status 0-2. Exclusion Criteria: Multifocal or multicentric cancer. Reception of neoadjuvant chemotherapy. Pure invasive lobular histology. Surgical margins<2mm. Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan. Measured maximum PTV of >124cc. Lumpectomy cavity within 5mm of body contour.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristin Webb, CCRP

Phone

(205) 975-9316

kkwebb@uabmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

D. Hunter Boggs, MD

Phone

(205) 975-5581

dhboggs@uabmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

D. Hunter Boggs, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC)

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35880164

Citation

Liu Y, Veale C, Hablitz D, Krontiras H, Dalton A, Meyers K, Dobelbower M, Lancaster R, Bredel M, Parker C, Keene K, Thomas E, Boggs D. Feasibility and Short-Term Toxicity of a Consecutively Delivered Five Fraction Stereotactic Body Radiation Therapy Regimen in Early-Stage Breast Cancer Patients Receiving Partial Breast Irradiation. Front Oncol. 2022 Jul 8;12:901312. doi: 10.3389/fonc.2022.901312. eCollection 2022.

Results Reference

derived

Learn more about this trial

RAD 1802: Pilot Trial of Dose Adapted Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

We'll reach out to this number within 24 hrs