Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Invasive Breast Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
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.
Investigators
Shannon MacDonald, MD
Attending Radiation Oncologist
Massachusetts General Hospital
Eligibility 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
Outcomes
Primary Outcomes
Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
Time Frame: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
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 adverse event within 3 months after the completion of radiation treatment.
Secondary Outcomes
- The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy(Baseline and then 4 and 8 weeks post treatment)
- The Number of Participants With Acute Skin Toxicities(From the start of treatment until 3 months after the end of treatment)
- Rate and Severity of Radiation Pneumonitis(From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.)
- Summary of Late Skin Toxicity(From 3 months after the end of treatment up to 5 years)
- To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome(From the start of treatment until 5 years post treatment)
- Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation(From the start of treatment until 5 years post treatment)
- Progression Free Survival(from the start of treatment until the time of disease progression, up to 5 years)
- The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction(From the start of treatment until 5 years post treatment)