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Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial


Phase 2
50 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial


Inclusion Criteria:



- Life expectancy > 10 years

- Lumpectomy with clear margins (negative per NSABP criteria)

- DCIS and/or invasive carcinoma

- If invasive, nodes must be negative

- T stage is Tis, T1 or T2<=3 cm max diameter

- ER(+) or ER(-)/PR(+)

Exclusion Criteria:

- Pregnant or breast feeding

- Active collagen-vascular disease

- Paget's disease of the breast

- Prior history of breast cancer

- Prior breast or thoracic radiotherapy

- Multicentric carcinoma

- Synchronous bilateral breast cancer

- Surgical margins that cannot be assessed or that are positive

- T Stage is T2>3 cm or greater

- ER(-)/PR(-)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Atif Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Institutional Review Board

Study ID:

S09-001

NCT ID:

NCT01072838

Start Date:

December 2009

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • breast cancer
  • APBI
  • brachytherapy
  • Contura
  • Breast Neoplasms

Name

Location
William Beaumont Hospital Royal Oak, Michigan  48073
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Virginia Commonwealth University Richmond, Virginia