Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
This study is currently recruiting participants.
Verified December 2012 by Brown University
Sponsor:
Jaroslaw Hepel
Collaborators:
The Miriam Hospital
Rhode Island Hospital
Information provided by (Responsible Party):
Jaroslaw Hepel, Brown University
ClinicalTrials.gov Identifier:
NCT01463007
First received: July 21, 2011
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: Accelerated partial breast irradiation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT |
Resource links provided by NLM:
Further study details as provided by Brown University:
Primary Outcome Measures:
- Early and intermediate toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years
Secondary Outcome Measures:
- Cosmetic outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria.
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radiation
AccuBoost APBI- 34.0 Gy in 10fx
|
Radiation: Accelerated partial breast irradiation
Accuboost APBI 34.0 Gy in 10 fractions
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A confirmed histological diagnosis of invasive breast carcinoma or DCIS
- Age greater or equal to 50 years old
- Life expectancy > 6 months
- Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy
- Pathologic tumor size less than or equal to 2 cm
- Invasive ductal, mucinous, tubular or colloid histology
- Estrogen receptor positive for invasive carcinoma.
- Unifocal/unicentric disease
- Negative surgical margins greater than or equal to 2 mm
- Pathologic lymph node negative
- No evidence of lymphovascular invasion
- ECOG performance status of 0 or 1 (Appendix 1)
- Informed consent signed.
Exclusion Criteria:
- Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
- Autoimmune disorder
- Pregnancy
- Breast implants
- Psychiatric or addictive disorder that would preclude attending follow-up
- Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
- Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
- Lobular features on histology (pure or mixed) or sarcoma histology
- Node positive on axillary dissection or in the sentinel lymph node biopsy;
- Extensive in situ carcinoma (EIC)
- Multicentric or multifocal disease
- Paget's disease of the nipple
- Distant metastases
- Lumpectomy cavity not well visualized on AccuBoost imaging
- Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)
- Breast separation with compression > 7cm.
- Overlap of skin between orthogonal treatment axes.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463007
Contacts
| Contact: kayla Rosati | 401-863-3000 | kayla_rosati@brown.edu |
Locations
| United States, Florida | |
| Center For Cancer Care and Research- Watson Clinic | Recruiting |
| Lakeland, Florida, United States, 33805 | |
| Contact: Susan Collins SCollins@watsonclinic.com | |
| United States, New York | |
| The Farber Center for Radiation Oncology | Recruiting |
| New York, New York, United States, 10007 | |
| Contact: Marnee Spierer, MD 212-300-0063 | |
| Principal Investigator: Marnee Spierer, MD | |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
| Contact: debora isdale 401-863-3000 debora_isdale@brown.edu | |
| Contact: kayla rosati 401-863-3000 kayla_rosati@brown.edu | |
| Lifespan Hospitals | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: debora g isdale 401-863-3000 debora_isdale@brown.edu | |
| Sub-Investigator: maureen Chung, MD | |
| Sub-Investigator: theresa graves, md | |
| United States, Washington | |
| Tacoma Radiation | Not yet recruiting |
| Tacoma, Washington, United States | |
| Contact: Rachel Rozgowski rrozgowski@tacomaradiation.com | |
| Principal Investigator: Dean Mastras, MD | |
Sponsors and Collaborators
Jaroslaw Hepel
The Miriam Hospital
Rhode Island Hospital
Investigators
| Principal Investigator: | Jaroslaw Hepel, MD | Brown University Oncology Research Group |
More Information
No publications provided
| Responsible Party: | Jaroslaw Hepel, principal investigator, Brown University |
| ClinicalTrials.gov Identifier: | NCT01463007 History of Changes |
| Other Study ID Numbers: | BrUOG 251 |
| Study First Received: | July 21, 2011 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brown University:
|
invasive ductal cancer tubular breast cancer breast cancer |
colloid ER positive radiation |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013