NCT03710733

Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS

Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (estimated)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.

Detailed description

This study is a prospective randomized non-inferiority trial of accelerated hypofractionated whole breast irradiation plus sequential boost versus concomitant boost after breast conservative surgery. It will be conducted on 124 patients who will be randomized using permuted blocks. The primary outcome measured is the cosmetic outcome, while secondary outcomes are patient satisfaction (using breast questionnaire), acute toxicity (using RTOG acute toxicity scoring criteria), and late toxicity (using RTOG late toxicity scoring criteria).

Conditions

• Radiotherapy Side Effect

Interventions

Type	Name	Description
RADIATION	Sequential boost	Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation
RADIATION	Concomitant boost	Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-10-18
• Last updated: 2020-09-11

Locations

1 site across 1 country: Egypt