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Status unknownNCT05609058Updated Jan 31, 2023

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

An interventional study of dedicated treatment board with no degree in Breast Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Jan 2019, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
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Study 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.

Read the detailed 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer
  • radiotherapy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 300 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Breast cancer underwent scanning in the supine position

    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

  • Devicededicated 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

06

What researchers measure

Primary outcomes

  1. dose distribution of GTV

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

    Time frame: 1 year

  2. dose distribution of CTV

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

    Time frame: 1 year

  3. dose distribution of PTV

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

    Time frame: 1 year

  4. dose distribution of heart

    the difference of heart dose distribution between two plans

    Time frame: 1 year

  5. dose distribution of ipsilateral lung

    the difference of ipsilateral lung dose distribution between two plans

    Time frame: 1 year

  6. dose distribution of bilateral breasts

    the difference of bilateral breasts dose distribution between two plans

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Shanxi provicial cancer hospital
    Taiyuan, Shanxi 030001, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05609058
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Responsible party
NING_LI (professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Nov 8, 2022
Start date
Jan 1, 2019
Primary completion
Nov 1, 2023 (estimated)
Completion
Nov 1, 2023 (estimated)
Last update
Jan 31, 2023

Study contacts

Ning Li
Contact
liningnci@126.com
13521952929

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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