The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Target

Breast Cancer Clinical Trial

Official title:

The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Irradiation for Chinese Breast Cancer Patients :Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609058
• Other study ID #: BC-2019
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Ning Li
• Phone: 13521952929
• Email: liningnci[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radiotherapy after breast conserving therapy plays an important role in early stage breast cancer patients. It not only results in a reduction in local and regional recurrence but also decrease the death rate effectively. For adjuvant radiotherapy, supine positioning is the most common approach and has multiple advantages. Due to deformability and softness of the breast, during simulation and treatment in supine position, the breast stretches over the chest wall, especially in patients with large and pendulous glands. Thus the organs at risk (OARs) received dose increased. The radiotherapeutic toxicity are unavoidable. Some present studies show that the prone positioning of patients can improve dose homogeneity and reduce the dose distribution in OARs in patients with large and pendulous glands. Chinese women have relatively small breasts, the advantages of those have not been established. Therefore, investigators compared the parameters between supine and prone positions for whole breast irradiation after conserving surgery.

Description:

Objective To investigate the difference of target volumes and dosimetric parameters between supine and prone positions for whole breast irradiation after conserving surgery.

Methods Breast cancer patients with T1-2N0M0 stage who underwent radiation therapy after conserving surgery were enrolled. Supine and Prone scan sets were acquired during free breathing for all patients. Target volumes and organs at risk (OARs) including heart, ipsilateral lung and bilateral breast were contoured by the same radiation oncologist. The tumor bed (TB) was determined based on surgical clips. The Clinical target volume (CTV)consisted of the whole breast. The planning target volume (PTV) was CTV plus 0.5cm. The boost of PTV (PTVboost) was TB plus 0.5cm. Dosimetric parameters of target volumes and OARs were compared between supine and prone position.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Breast cancer patients with T1-T2N0M0 stage who underwent radiation therapy after conserving surgery

2. exhibited normal arm movement a?ter surgery

3. had no chronic lung diseases

4. Written informed consent forms

Exclusion Criteria:

1. Breast cancer patients with radical surgery

2. could not exhibit normal arm movement after surgery

3. had chronic lung diseases

4. refused informed consent forms

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• dedicated treatment board with no degree
the patients were placed in the prone position on a dedicated treatment board with no degree incline using an arm support (with both arms above the head). Te board contained an open aperture on one side to allow for the ipsilateral breast to hang freely away from the chest wall

Locations

Country	Name	City	State
China	Shanxi provicial cancer hospital	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dose distribution of GTV	the difference of GTV (Gross tumor target) between two plans	1 year
Primary	dose distribution of CTV	the difference of CTV (clinical target volume) between two plans	1 year
Primary	dose distribution of PTV	the difference of PTV (planing target volume) between two plans	1 year
Primary	dose distribution of heart	the difference of heart dose distribution between two plans	1 year
Primary	dose distribution of ipsilateral lung	the difference of ipsilateral lung dose distribution between two plans	1 year
Primary	dose distribution of bilateral breasts	the difference of bilateral breasts dose distribution between two plans	1 year