Clinical trial NCT01340495: Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
Official title: Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Invasive Breast Cancer
Keywords: Breast Cancer
Mastectomy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-04-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
timeFrame: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
Secondary outcomes:
measure: The Number of Participants With Acute Skin Toxicities
timeFrame: From the start of treatment until 3 months after the end of treatment
measure: Rate and Severity of Radiation Pneumonitis
timeFrame: From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
measure: Summary of Late Skin Toxicity
timeFrame: From 3 months after the end of treatment up to 5 years
measure: To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome
timeFrame: From the start of treatment until 5 years post treatment
measure: Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation
timeFrame: From the start of treatment until 5 years post treatment
measure: The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction
timeFrame: From the start of treatment until 5 years post treatment
measure: The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy
timeFrame: Baseline and then 4 and 8 weeks post treatment
measure: Progression Free Survival
timeFrame: from the start of treatment until the time of disease progression, up to 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Shannon M MacDonald, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jimenez RB, Hickey S, DePauw N, Yeap BY, Batin E, Gadd MA, Specht M, Isakoff SJ, Smith BL, Liao EC, Colwell AS, Ho A, Januzzi JL, Passeri J, Neilan TG, Taghian AG, Lu HM, MacDonald SM. Phase II Study of Proton Beam Radiation Therapy for Patients With Breast Cancer Requiring Regional Nodal Irradiation. J Clin Oncol. 2019 Oct 20;37(30):2778-2785. doi: 10.1200/JCO.18.02366. Epub 2019 Aug 26.