Hypofractionated Radiotherapy in Breast Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2019-05-14

Brief Summary

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As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT.

The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.

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Detailed Description

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As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT.

The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.

Investigators seek to assess the rate of cutaneous toxicity, the rates of lymphedema determined by arm measurements and Grade 3 brachial plexopathy in patients receiving regional nodal irradiation, as well as local control, quality of life, and fatigue levels.

Conditions

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Cancer, Breast Inflammation

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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Participants with Stage 0-III breast cancer

Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.

Group Type EXPERIMENTAL

Hypofractionated Simultaneous Integrated Boost Radiotherapy

Intervention Type RADIATION

Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.

Interventions

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Hypofractionated Simultaneous Integrated Boost Radiotherapy

Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

Participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy:

* Prior Chemotherapy for Breast Cancer
* Greater than 25 cm of breast separation (the largest distance on an axial slice of the planning CT simulation scan between the entry and exit points of the radiation beam on the body)
* Non-Caucasian Race
* Less than or equal to 50 years of age
* Requiring regional nodal irradiation without evidence of N3 disease