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RecruitingNCT04985032

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

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

Sponsor

RPCR, Inc.

Enrollment

200 participants

Start Date

Aug 15, 2022

Study Type

OBSERVATIONAL

Conditions

Ductal Carcinoma in SituInvasive Ductal Carcinoma of Female Breast

Summary

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

Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 100 Years

Inclusion Criteria11

  • 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 Criteria17

  • 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

Interventions

RADIATIONstereotactic body radiation therapy

Treatment technique used to deliver a highly focused and accurate radiation dose to a defined target volume outside the brain; the entire course of therapy delivered in five fractions or less

Locations(2)

CyberKnife Center of South Florida in Stuart

Stuart, Florida, United States

CyberKnife Centers of Tampa Bay

Tampa, Florida, United States

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NCT04985032

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