Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02457117
Recruitment Status : Recruiting
First Posted : May 29, 2015
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
This study is a registry to monitor quality of life and clinical outcomes in patients with clinically localized breast cancer who have received stereotactic accelerated partial breast irradiation via CyberKnife.

Condition or disease Intervention/treatment
Breast Cancer Radiation: CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)

Detailed Description:

Radiotherapy for breast cancer is delivered using several whole breast and partial breast approaches. The optimal approach is unknown. The utilization of partial breast irradiation is growing due to the convenience of fewer fractions versus fifteen- thirty treatments required with conventional or hypofractionated whole breast radiation therapy.

Early results with partial breast techniques are promising, showing similar cancer control and toxicity. There is a large body of mature Phase I/II and preliminary Phase III data available exploring the replacement of WBI with an accelerated course of radiation therapy restricted to the region around the tumor bed (accelerated Partial Breast Irradiation, aPBI) using a variety of techniques. For appropriately selected patients treated with modern techniques, the results are encouraging and the techniques have been shown to be safe, tolerable, and highly reproducible with outcomes similar to WBI.

Currently, there is limited data assessing the quality of life, cosmetic and oncologic outcomes following stereotactic partial breast irradiation in a large patient population. Our study will be the first essential step in aggregating the outcomes of patients undergoing this type of external beam irradiation in a large patient population.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)
Study Start Date : May 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)
    Five fraction radiation therapy to the lumpectomy cavity
    Other Names:
    • Breast SBRT
    • partial breast irradiation


Primary Outcome Measures :
  1. In breast failure [ Time Frame: 5 years ]
    To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI


Secondary Outcome Measures :
  1. Cosmesis [ Time Frame: 5 years ]
    Treatment related Cosmesis based on the Harvard Cosmesis Scale

  2. Regional Recurrence [ Time Frame: 5 years ]
    Regional recurrence free interval defined as time from end of radiation treatment to the diagnosis of disease in the regional lymph nodes

  3. Distant Recurrence [ Time Frame: 5 years ]
    Distant disease free interval defined as the time from end of radiation treatment to first diagnosis of distant disease, regardless of the occurrence of any intervening local or regional failure, contralateral breast cancer, or non-breast second primary cancer

  4. Adverse reactions [ Time Frame: 5 years ]
    Toxicity from treatment based on CTCAE version 4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women receiving breast cancer treatment.
Criteria

Inclusion Criteria:

  • Subjects are eligible to participate in the registry if they receive CK-SAPBI in 5 fractions within 12 weeks of surgery and sign an institution specific consent form.

Additionally, subjects will be considered standard risk and optimal for CK-SAPBI if they meet the following criteria:

  • Newly diagnosed AJCC (seventh edition) Stage 0 or I breast cancer.
  • On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast
  • Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy
  • Age 50 years or greater
  • ER positive
  • PR positive
  • Her2 negative (IHC 0-1+; for IHC 2+, FISH must be non-amplified)
  • Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection.
  • Negative inked surgical margins of excision or re-excision, clear of invasive tumor and DCIS by at least 2 mm
  • Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications.
  • No involved axillary lymph nodes, N0(i+) allowed
  • Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT

Exclusion Criteria:

  • -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
  • Patients with tumors greater than 2 cm
  • Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation.
  • Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be required to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
  • Patients with involved axillary nodes.
  • Patients with collagen vascular diseases (active).
  • Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN, CDH1)
  • Patients with prior ipsilateral breast irradiation.
  • Patients with prior ipsilateral thoracic irradiation.
  • Patients with Paget's disease of the nipple.
  • Patients with diffuse suspicious microcalcifications.
  • Patients with suspicious microcalcifications remaining on the post-excision mammogram.
  • Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy
  • Patients with oncoplastic reconstruction and absence of surgical clips

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457117


Contacts
Layout table for location contacts
Contact: Olusola Obayomi-Davies, M.D. 6104465860 olusola.obayomi-davies@crozer.org
Contact: Michael Repka, M.D. 2024443320 michael.c.repka@gunet.georgetown.edu

Locations
Layout table for location information
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20008
Contact: Olusola OBAYOMI-DAVIES, M.D    202-444-3320    olusola.obayomi-davies@medstar.net   
Principal Investigator: Olusola Obayomi-Davies, M.D         
Sponsors and Collaborators
Georgetown University
Additional Information:

Layout table for additonal information
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02457117    
Other Study ID Numbers: 2015-0098
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Keywords provided by Georgetown University:
CyberKnife
Partial breast irradiation
accelerated partial breast irradiation
breast sbrt