Breast CancerNCT05609058
The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Target
A study testing dedicated treatment board with no degree in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- dedicated treatment board with no degree
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Breast cancer patients with radical surgery
- could not exhibit normal arm movement after surgery
- had chronic lung diseases
- refused informed consent forms
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanxi provicial cancer hospital
Taiyuan, Shanxi, 030001
Ning Li, 13521952929, liningnci@126.com
About this study
Official title: The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Irradiation for Chinese Breast Cancer Patients :Comparative Study
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.
- Conditions
- Breast Cancer
- Being tested
- dedicated treatment board with no degree
- Keywords
- Breast cancer, radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dedicated treatment board with no degreeDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: dedicated treatment board with no degree |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose distribution of GTV
the difference of GTV (Gross tumor target) between two plans
Measured: 1 year
dose distribution of CTV
the difference of CTV (clinical target volume) between two plans
Measured: 1 year
dose distribution of PTV
the difference of PTV (planing target volume) between two plans
Measured: 1 year
dose distribution of heart
the difference of heart dose distribution between two plans
Measured: 1 year
dose distribution of ipsilateral lung
the difference of ipsilateral lung dose distribution between two plans
Measured: 1 year
dose distribution of bilateral breasts
the difference of bilateral breasts dose distribution between two plans
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Jan 2019
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NING_LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609058
- Sponsor's protocol ID
- BC-2019
- Status last verified
- Jan 2023
- First submitted
- 24 Oct 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feng L, Liang Y, Huang J, Xu S, Zhang W, Su X, Tan Y, Lei T, Xiang X, Chen L, Lei J, Hu N, Jin J, Xiao Q, Li N. Evaluation of organs at risk (OARs) in whole-breast irradiation: a comparison of prone, supine position and with deep inspiration breath-hold techniques-subgroup analysis from a prospective study. BMC Cancer. 2026 Jan 22;26(1):307. doi: 10.1186/s12885-025-15445-6.
PubMed 41572204Ma 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.
PubMed 37946125
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Irradiation for Chinese Breast Cancer Patients :Comparative Study
- ClinicalTrials.gov ID
- NCT05609058
- Acronym / sponsor ID
- BC-2019
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Breast cancer underwent scanning in the supine position | Experimental | Device: dedicated treatment board with no degreeBreast 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Breast cancer patients with radical surgery
- could not exhibit normal arm movement after surgery
- had chronic lung diseases
- refused informed consent forms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dedicated treatment board with no degreethe 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 | Device | Breast cancer underwent scanning in the supine position |
Primary outcome
dose distribution of GTV
Time frame: 1 year
the difference of GTV (Gross tumor target) between two plans
dose distribution of CTV
Time frame: 1 year
the difference of CTV (clinical target volume) between two plans
dose distribution of PTV
Time frame: 1 year
the difference of PTV (planing target volume) between two plans
dose distribution of heart
Time frame: 1 year
the difference of heart dose distribution between two plans
dose distribution of ipsilateral lung
Time frame: 1 year
the difference of ipsilateral lung dose distribution between two plans
dose distribution of bilateral breasts
Time frame: 1 year
the difference of bilateral breasts dose distribution between two plans
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 41572204Feng L, Liang Y, Huang J, Xu S, Zhang W, Su X, Tan Y, Lei T, Xiang X, Chen L, Lei J, Hu N, Jin J, Xiao Q, Li N. Evaluation of organs at risk (OARs) in whole-breast irradiation: a comparison of prone, supine position and with deep inspiration breath-hold techniques-subgroup analysis from a prospective study. BMC Cancer. 2026 Jan 22;26(1):307. doi: 10.1186/s12885-025-15445-6.
- Derived from this study: PubMed 37946125Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dedicated treatment board with no degree in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Li (13521952929, liningnci@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose distribution of GTV (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05609058, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.