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Trial Title:
Prospective Study of Particle Radiotherapy for Breast Cancer With Different Arm Position
NCT ID:
NCT05878678
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
immobilization positions
breast cancer
particle radiotherapy
dosimetry
multi-modal guided radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Fixed positions of arm down and arm up
Description:
In order to explore the accuracy of breast cancer patients' treatment positions and its
impact on dose of the new fixation device in two different fixed positions of arm up and
arm down, optimize the position fixed equipment and methods of particle radiotherapy for
breast cancer, and then establish the precision process of particle radiotherapy for
breast cancer under the guidance of multimodal images.
Arm group label:
Fixed positions of arm down
Arm group label:
Fixed positions of arm up
Summary:
The optical body surface image (C-RAD) was used to guide and track the change of
positions, and multimodal images (including 2D X-ray images, CT images and PET-CT images)
were used to verify the treatment positions. In order to explore the accuracy of breast
cancer patients' treatment positions and its impact on dose of the new fixation device in
two different fixed positions of arm up and arm down, optimize the position fixed
equipment and methods of particle radiotherapy for breast cancer, and then establish the
precision process of particle radiotherapy for breast cancer under the guidance of
multimodal images. In a word, this is a dosimetry and prospective Phase II randomized
clinical study of the accuracy of multi-modal guided particle radiotherapy for
postoperative breast cancer with different arm position.
Detailed description:
PET-CT: Positron Emission Tomography - Computed Tomography CT: Computed Tomography
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with pathologically (cytological or histological) confirmed breast cancer
with positive lymph nodes and postoperative adjuvant radiotherapy
2. Exclude distant metastasis
3. No ipsilateral breast and breast radiation therapy
4. Exclude patients requiring axillary irradiation
5. Age 18-80 years old
6. General good health (Eastern Cooperative Oncology Group, ECOG 0-2)
7. No complications such as severe pulmonary hypertension, cardiovascular disease,
peripheral vascular disease, or severe chronic heart disease that may affect
radiotherapy.
8. Non-pregnant (confirmed by serum or urine β-HCG test) or lactating women
9. Patients must sign informed consent to receive radiotherapy.
Exclusion Criteria:
1. Pathology unapproved breast cancer
2. With distant metastasis
3. The ipsilateral breast or breast has received radiation therapy
4. Patients requiring axillary irradiation
5. The dose limit of organs at risk cannot reach the preset safe dose limit
6. Pregnancy (confirmed by serum or urine β-HCG test) or lactation
7. Poor general health, Karnofsky Performance Status (KPS)<70，or ECOG>2
8. Severe complications that may affect radiotherapy, including: a) Unstable angina
pectoris, congestive heart failure, myocardial infarction requiring hospitalization
in the past 6 months, b) acute bacterial or systemic fungal infection, c)
hospitalization for exacerbations of chronic obstructive pulmonary disease (COPD) or
other respiratory diseases
9. Unable to understand the purpose of treatment or unwilling to sign the treatment
consent
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Proton and Heavy Ion Center
Address:
City:
Shanghai
Zip:
201321
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingfang Zhao
Phone:
+86 021-38296666
Email:
jingfang.zhao@sphic.org.cn
Contact backup:
Last name:
Ping Li
Phone:
+86 021-38296666
Email:
ping.li@sphic.org.cn
Start date:
May 15, 2023
Completion date:
July 30, 2024
Lead sponsor:
Agency:
Shanghai Proton and Heavy Ion Center
Agency class:
Other
Source:
Shanghai Proton and Heavy Ion Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05878678
