RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-08-15
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04985032

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.

Ages Eligible for Study:50 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Women 50 years or older
  2. 2. Low to intermediate grade DCIS or invasive ductal carcinoma
  3. 3. Tumor size \< 2 cm invasive ductal carcinoma and \< 2.5 cm DCIS
  4. 4. Well defined lumpectomy cavity on CT
  5. 5. Clear surgical ink margins \> 2mm for invasive cancer and \> 3 mm for DCIS
  6. 6. Node negative
  7. 7. Unifocal lesion
  8. 8. ER and/or PR positive
  9. 9. HER-2 negative
  10. 10. BRCA negative
  11. 11. Lumpectomy cavity must be \< 30% of whole breast volume
  1. 1. Lobular histology
  2. 2. Angiolymphatic invasion
  3. 3. Multiple foci of disease
  4. 4. Lymphovascular invasion
  5. 5. Active lupus or sarcoid
  6. 6. Distant metastases
  7. 7. Non-epithelial malignancies
  8. 8. Synchronous contralateral breast cancer
  9. 9. Grade 2 or higher oncoplastic surgery
  10. 10. Ipsilateral pacemaker
  11. 11. Ipsilateral breast implant
  12. 12. Neoadjuvant chemotherapy
  13. 13. Prior ipsilateral breast cancer or thoracic radiation
  14. 14. Poor breast integrity
  15. 15. Paget's Disease of the nipple
  16. 16. Pregnant patients
  17. 17. Severe cardiac, pulmonary, or liver diseases

Contacts and Locations

Study Contact

Mark Perman, MD
CONTACT
772-293-0377
Mark.Perman@usa.genesiscare.com
Debra Freeman, MD
CONTACT
239-262-5168
tbck.md@gmail.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: RPCR, Inc.

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 Registration Dates

Study Start Date2022-08-15
Study Completion Date2027-06

Study Record Updates

Study Start Date2022-08-15
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Ductal Carcinoma in Situ
  • Invasive Ductal Carcinoma of Female Breast