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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Breast Cancer Female

Treatments: Device: Prone crawl positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05179161

EC-UZ-2016/0351

B670201628048 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients
• Non-metastasized breast carcinoma
• Multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer
• Prone WBI without LNI indicated according to the department's guidelines, treatment schedule of at least 15 fractions
• Age ≥ 18 years
• Informed consent obtained, signed and dated before specific protocol procedures

Exclusion criteria

• < 18 years old
• Mastectomy
• Need for LNI
• Bilateral breast irradiation
• Partial breast irradiation
• Unable to be treated in prone position
• Less than 15 treatment fractions planned
• Situs inversus
• Pregnant or breastfeeding
• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
• Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Prone crawl position

Experimental group

Description:

Patients are placed in the prone crawl position for whole breast irradiation and are treated with 15 x 2,67 Gy (± boost treatment if required as per international guidelines)

Treatment:

Device: Prone crawl positioning