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

NCT ID: NCT05609058

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-11-01

Brief Summary

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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

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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

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

dedicated treatment board with no degree

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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NING_LI

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanxi provicial cancer hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ning Li

Role: CONTACT

13521952929

Facility Contacts

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Ning Li

Role: primary

13521952929

References

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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.

Reference Type DERIVED
PMID: 37946125 (View on PubMed)

Other Identifiers

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BC-2019

Identifier Type: -

Identifier Source: org_study_id

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