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Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy


N/A
18 Years
N/A
Open (Enrolling)
Both
Invasive Breast Cancer

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Trial Information

Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy


Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be
assessed weekly for any side effects they may be experiencing.

Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12
months, and then every year for up to five years after treatment. Follow-up visits will
include a physical examination, radiological imaging (if necessary), echocardiogram, and
laboratory tests.


Inclusion Criteria:



- Histologically confirmed invasive breast cancer confined to the breast and regional
lymphatics

- Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery

- Life expectancy > 12 months

Exclusion Criteria:

- Pregnant or breast-feeding

- Prior therapeutic radiation > 200 cGy

- History of a different malignancy unless disease-free for at least 5 years or
diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of
the skin

- Prior investigation chemotherapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy

Outcome Description:

To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 toxicity within 3 months after the completion of radiation treatment.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Shannon M MacDonald, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

10-205

NCT ID:

NCT01340495

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Invasive Breast Cancer
  • Breast Cancer
  • Mastectomy
  • Breast Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617