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

RPCR, Inc. · with CyberKnife Coalition · NCT04985032

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50–100 · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
200
US sites recruiting
2
Study start
August 15, 2022
Record last updated
August 5, 2022

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: stereotactic body radiation therapy

Conditions: Ductal Carcinoma in Situ; Invasive Ductal Carcinoma of Female Breast

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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

Exclusion Criteria

  • Lobular histology
  • Angiolymphatic invasion
  • Multiple foci of disease
  • Lymphovascular invasion
  • Active lupus or sarcoid
  • Distant metastases
  • Non-epithelial malignancies
  • Synchronous contralateral breast cancer
  • Grade 2 or higher oncoplastic surgery
  • Ipsilateral pacemaker
  • Ipsilateral breast implant
  • Neoadjuvant chemotherapy
  • Prior ipsilateral breast cancer or thoracic radiation
  • Poor breast integrity
  • Paget's Disease of the nipple
  • Pregnant patients
  • Severe cardiac, pulmonary, or liver diseases

Recruiting US locations

  • CyberKnife Center of South Florida in Stuart

    Stuart, FL 33996

    Site contact: Mark Perman, MD · 772-403-2390

  • CyberKnife Centers of Tampa Bay

    Tampa, FL 33615

    Site contact: Debra Freeman, MD · 813-884-7400 · dfreeman_md@yahoo.com

Study contacts (from the official record)

  • Mark Perman, MD · 772-293-0377 · Mark.Perman@usa.genesiscare.com
  • Debra Freeman, MD · 239-262-5168 · tbck.md@gmail.com
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Accelerated Partial Breast Irradiation (APBI) Using Stereotactic… (NCT04985032) | Bored Studies