Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

August 3, 2022 updated by: RPCR, Inc.

Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial

This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

RADIATION TREATMENT GUIDELINES and DOSIMETRY Fiducial Placement Prior to enrollment, patients will undergo breast conservation surgery preferably with fiducial markers implanted at the time of surgery or under ultrasonic guidance25

Patients treated with gantry-based SBRT preferably will have fiducials placed at the time of surgery.

For patients being treated with CyberKnife SBRT, four gold markers will be placed intraoperatively or ultrasonically to define the superior, inferior, medial, and lateral boundaries of the lumpectomy cavity in accordance with the manufacturer's (Accuray) documentation. At least three fiducials will be required for target tracking purposes to allow for rotational changes.

Simulation Linear Accelerator SBRT For treatments on a gantry-based linear accelerator, patients will be positioned supine with the arms elevated. CT scans will be obtained with 1.25 mm thickness and will be acquired with free breathing as well as additional scans as needed for motion control or gating. 4DCT, MRI and PET imaging may be used to assist in determining motion estimation.

CyberKnife SBRT For treatment on a robotic system, a contrast enhanced CT simulation is to be performed with 1 mm slices with the patient's arms at her sides in the supine position. The scan is to be performed with end-inspiratory breath hold from the thyroid to below the lungs. Breast immobilization devices including a vacuum mattress and a bra system will be allowed however bolus should not be used. Fiducial tracking (Synchrony) is to be used for motion tracking.

DOSIMETRY Target and Organs at Risk (OAR) contours

The following structures are to be contoured in all patients:

Tumor cavity (GTV) as defined on CT including all fiducials implanted on CT images Clinical Target Volume (CTV) defined as the tumor cavity expanded by a uniform 15 mm margin. The CTV will not extend beyond the skin, breast or chestwall Planning Tumor Volume (PTV) for SBRT will be defined as the CTV plus 3 - 5 mm as needed at the treating physician's discretion. PTV will be limited to GTV plus 20 mm margin Skin is defined as <5 mm inside the external contour Chest wall includes the ribs and intercoastal musculature but does not include the pectoralis Heart contour begins below the level of where the pulmonary trunk branches into the left and right pulmonary arteries Lungs are to be contoured separately Spinal canal Breasts are to be contoured separately Dose Prescription The total prescribed dose to the PTV is 30 Gy delivered in 5 equal fractions of 6 Gy per day delivered on alternating days over 5 -10 total days. The prescribed dose must cover at least 95% of the PTV.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Stuart, Florida, United States, 33996
        • Recruiting
        • CyberKnife Center of South Florida in Stuart
      • Tampa, Florida, United States, 33615
        • Recruiting
        • CyberKnife Centers of Tampa Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

SBRT for treatment of the surgical cavity following partial mastectomy for women with early-stage breast cancer will be studied.

Description

Inclusion Criteria:

  1. Women 50 years or older
  2. Low to intermediate grade DCIS or invasive ductal carcinoma
  3. Tumor size < 2 cm invasive ductal carcinoma and < 2.5 cm DCIS
  4. Well defined lumpectomy cavity on CT
  5. Clear surgical ink margins > 2mm for invasive cancer and > 3 mm for DCIS
  6. Node negative
  7. Unifocal lesion
  8. ER and/or PR positive
  9. HER-2 negative
  10. BRCA negative
  11. Lumpectomy cavity must be < 30% of whole breast volume

Exclusion Criteria:

  1. Lobular histology
  2. Angiolymphatic invasion
  3. Multiple foci of disease
  4. Lymphovascular invasion
  5. Active lupus or sarcoid
  6. Distant metastases
  7. Non-epithelial malignancies
  8. Synchronous contralateral breast cancer
  9. Grade 2 or higher oncoplastic surgery
  10. Ipsilateral pacemaker
  11. Ipsilateral breast implant
  12. Neoadjuvant chemotherapy
  13. Prior ipsilateral breast cancer or thoracic radiation
  14. Poor breast integrity
  15. Paget's Disease of the nipple
  16. Pregnant patients
  17. Severe cardiac, pulmonary, or liver diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS)
Time Frame: 2-3 years
physician and patient assessment of breast cosmetic result following SBRT
2-3 years
Acute breast toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame: 1-6 weeks
assessment of skin and breast tissue changes during and immediately following SBRT
1-6 weeks
Other late toxicities as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame: 3-60 months
assessment of pulmonary, cardiac and chest wall changes following SBRT
3-60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RPCR, Inc.

Collaborators

CyberKnife Coalition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 15, 2022

Primary Completion (ANTICIPATED)

August 15, 2024

Study Completion (ANTICIPATED)

June 1, 2027

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (ACTUAL)

August 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPCR-breast 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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