RECRUITING

RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

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Conditions

Breast CancerSBRTEarly stageRadiation therapy

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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 study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

Official Title

RAD 1802: a Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Quick Facts

Study Start:2019-08-20
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03643861

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:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed.
  2. * Age\>50.
  3. * Maximum pathologic tumor size \<2.0cm if invasive carcinoma or \< 2.5cm if pure DCIS.
  4. * Estrogen receptor (ER) positive (\>10%).
  5. * Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm.
  6. * Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative.
  7. * Zubrod Performance Status 0-2.
  1. * Multifocal or multicentric cancer.
  2. * Reception of neoadjuvant chemotherapy.
  3. * Pure invasive lobular histology.
  4. * Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
  5. * Measured maximum PTV of \>124cc.
  6. * Lumpectomy cavity within 5mm of body contour.

Contacts and Locations

Study Contact

D. Hunter Boggs, MD
CONTACT
(205) 934-5670
dhboggs@uabmc.edu
D. Hunter Boggs, MD
CONTACT
(205) 975-5581
dhboggs@uabmc.edu

Principal Investigator

D. Hunter Boggs, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC)
Birmingham, Alabama, 35233
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • D. Hunter Boggs, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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 Date2019-08-20
Study Completion Date2028-12

Study Record Updates

Study Start Date2019-08-20
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • SBRT
  • Breast cancer
  • Early stage
  • Radiation therapy

Additional Relevant MeSH Terms

  • Breast Cancer