Clinical trial NCT05609058: The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Target
Official title: The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Irradiation for Chinese Breast Cancer Patients :Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
radiotherapy
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: dose distribution of GTV
timeFrame: 1 year
measure: dose distribution of CTV
timeFrame: 1 year
measure: dose distribution of PTV
timeFrame: 1 year
measure: dose distribution of heart
timeFrame: 1 year
measure: dose distribution of ipsilateral lung
timeFrame: 1 year
measure: dose distribution of bilateral breasts
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi provicial cancer hospital
state: Shanxi
Study officials:
References: