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

Description

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

Conditions

Ductal Carcinoma in Situ, Invasive Ductal Carcinoma of Female Breast

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Ductal Carcinoma in Situ
Intervention / Treatment

-

Contacts and Locations

Stuart

CyberKnife Center of South Florida in Stuart, Stuart, Florida, United States, 33996

Tampa

CyberKnife Centers of Tampa Bay, Tampa, Florida, United States, 33615

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

50 Years to 100 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

RPCR, Inc.,

Study Record Dates

2027-06