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

NCT05609058 | Unknown

• 1 other identifier: BC-2019
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast cancer; radiotherapy

Outcome Measures

Primary Outcomes (6)

• dose distribution of GTV

  the difference of GTV (Gross tumor target) between two plans

  1 year

• dose distribution of CTV

  the difference of CTV (clinical target volume) between two plans

  1 year

• dose distribution of PTV

  the difference of PTV (planing target volume) between two plans

  1 year

• dose distribution of heart

  the difference of heart dose distribution between two plans

  1 year

• dose distribution of ipsilateral lung

  the difference of ipsilateral lung dose distribution between two plans

  1 year

• dose distribution of bilateral breasts

  the difference of bilateral breasts dose distribution between two plans

  1 year

Study Arms (1)

Breast cancer underwent scanning in the supine position

EXPERIMENTAL

Breast cancer patients with T1-2N0M0 stage who underwent radiation therapy after conserving surgery were enrolled. Supine 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.

Device: dedicated treatment board with no degree

Interventions

dedicated treatment board with no degree DEVICE

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

Breast cancer underwent scanning in the supine position

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patients with T1-T2N0M0 stage who underwent radiation therapy after conserving surgery
• exhibited normal arm movement aſter surgery
• had no chronic lung diseases
• Written informed consent forms

You may not qualify if:

• Breast cancer patients with radical surgery
• could not exhibit normal arm movement after surgery
• had chronic lung diseases
• refused informed consent forms

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Shanxi provicial cancer hospital

Taiyuan, Shanxi, 030001, China

RECRUITING

Related Publications (1)

• Ma L, Yang Y, Ma J, Mao L, Li X, Feng L, Abulimiti M, Xiang X, Fu F, Tan Y, Zhang W, Li YX, Jin J, Li N. Correlation between AI-based CT organ features and normal lung dose in adjuvant radiotherapy following breast-conserving surgery: a multicenter prospective study. BMC Cancer. 2023 Nov 9;23(1):1085. doi: 10.1186/s12885-023-11554-2.

  PMID: 37946125 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ning Li

CONTACT

13521952929; liningnci@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Breast cancer patients with T1-T2N0M0 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.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 8, 2022
• Study Start: January 1, 2019
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

CN (1)