NCT03320421

Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery

Phase II Trial of Hypofractionated Whole-breast Radiation and Concomitant Boost to the Surgical Bed After Breast Conserving Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.

Detailed description

OBJECTIVES: Primary: To determine the toxicity with adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost (SIB) in women with early breast cancer after breast conserving surgery. Secondary: To determine the short term cosmetic and quality of life of the participants treated with this regimen. To determine the local control of the participants treated with this regimen. OUTLINE: Patients undergo adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost once daily a week for 3 weeks. Toxicity, quality of life and cosmetic result is assessed before radiation, at the end of the radiation, within 2, 4, 6 weeks after completion of radiotherapy, and then every 3 months for 1 ear. PROJECTED ACCRUAL: A total of 90 participants will be accrued for this study.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
RADIATION	Radiation therapy	Radiation to the whole breast: 43.5 Gy in 15 fractions in 3 weeks. Simultaneous radiation to the surgical cavity: 49.5 Gy in 15 fractions in 3 weeks. Intensity modulated radiation treatment is used.

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2017-10-25
• Last updated: 2019-01-31

Locations

1 site across 1 country: China