NCT03167359

Hypofractionated Radiotherapy in Breast Cancer

A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cancer, Breast
• Inflammation

Interventions

Type	Name	Description
RADIATION	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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2019-05-14
• Completion: 2019-05-14
• First posted: 2017-05-30
• Last updated: 2021-05-07
• Results posted: 2021-05-07

Locations

1 site across 1 country: United States