NCT05762900

Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients

Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.

Detailed description

During the study, the patients would undergo radiation of 5.2Gy for 5 fractions to the prophylactic radiation volumes and and a 6Gy per-fraction simultaneous boost to the tumor bed or other high-risk volumes. Acute toxicity of grade 2 or higher in the following 12 weeks after radiotherapy is the primary end point.

Conditions

• Breast Cancer
• Radiotherapy Side Effect

Interventions

Type	Name	Description
RADIATION	Ultra-fractionated radiation therapy	5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.

Timeline

• Start date: 2022-10-25
• Primary completion: 2025-10-25
• Completion: 2030-10-25
• First posted: 2023-03-10
• Last updated: 2023-03-10

Locations

1 site across 1 country: China