Hypofractionated Radiotherapy in Breast Cancer

Emory University

Status: Completed

Conditions: Inflammation; Cancer, Breast

Treatments: Radiation: Hypofractionated Simultaneous Integrated Boost Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03167359

IRB00047240

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 74 patients

Sex: Female

Ages: Under 50 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Males will be excluded
• Women who are pregnant or nursing a child may not take part in this study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Participants with Stage 0-III breast cancer

Experimental group

Description:

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.

Treatment:

Radiation: Hypofractionated Simultaneous Integrated Boost Radiotherapy