Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shannon MacDonald, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01340495
First received: April 20, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.


Condition Intervention
Invasive Breast Cancer
Radiation: Proton Radiation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • To evaluate the rate and severity of acute skin toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • To evaluate the rate and severity of radiation pneumonitis, a sub-acute toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • To evaluate the rate and severity of late skin toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • To evaluate cosmetic outcome and patient satisfaction with cosmetic outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To evaluate acute and late toxicity of breast reconstruction following proton radiation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • To evaluate the need for unplanned additional surgery for breast reconstruction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • To evaluate early signs of cardiac effects from radiation therapy using Strain Echocardiogram [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To describe the 5 year progression free survival rate of patients with breast cancer treated with proton radiation


Estimated Enrollment: 52
Study Start Date: June 2011
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiation
Radiation therapy with proton beam
Radiation: Proton Radiation
45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340495

Contacts
Contact: Shannon M MacDonald, M.D. 617-729-8650 smacdonald@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Shannon M MacDonald, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Shannon M MacDonald, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Shannon MacDonald, MD, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01340495     History of Changes
Other Study ID Numbers: 10-205
Study First Received: April 20, 2011
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Breast Cancer
Mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014