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

NCT ID: NCT05179161

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-03-29

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Prone crawl position

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)

Group Type: EXPERIMENTAL

Prone crawl positioning

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liv Veldeman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

References

Deseyne P, Speleers B, De Neve W, Boute B, Paelinck L, Vakaet V, Van Hulle H, Schoepen M, Stouthandel M, Van Greveling A, Post G, Detand J, Monten C, Depypere H, Veldeman L. Crawl positioning improves set-up precision and patient comfort in prone whole breast irradiation. Sci Rep. 2020 Oct 2;10(1):16376. doi: 10.1038/s41598-020-72702-3.

Reference Type: RESULT

PMID: 33009448 (View on PubMed)

Deseyne P, Speleers B, Paelinck L, De Gersem W, De Neve W, Schoepen M, Van Greveling A, Van Hulle H, Vakaet V, Post G, Monten C, Depypere H, Veldeman L. Reproducibility of repeated breathhold and impact of breathhold failure in whole breast and regional nodal irradiation in prone crawl position. Sci Rep. 2022 Feb 3;12(1):1887. doi: 10.1038/s41598-022-05957-7.

Reference Type: DERIVED

PMID: 35115610 (View on PubMed)

Other Identifiers

B670201628048

Identifier Type: REGISTRY

Identifier Source: secondary_id

EC-UZ-2016/0351

Identifier Type: -

Identifier Source: org_study_id