NCT05179161

Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for WBI without LNI after breast-conserving surgery will be included after signing informed consent.

Detailed description

This is a phase II non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. Patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 Gy in 15 fractions of 2.67 Gy. The trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. Feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated. This is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DEVICE	Prone crawl positioning	Breast cancer patients are placed in a prone position with the ipsilateral arm besides the body rather than extended besides the head on a dedicated couch that provides the required support for maintaining this position.

Timeline

• Start date: 2016-05-31
• Primary completion: 2016-09-29
• Completion: 2017-03-29
• First posted: 2022-01-05
• Last updated: 2022-01-05