Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

Study Results

Results available

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Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Invasive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Proton Radiation

Radiation therapy with proton beam

Group Type EXPERIMENTAL

Proton Radiation

Intervention Type 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

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No