Clinical trial NCT05878678: Prospective Study of Particle Radiotherapy for Breast Cancer With Different Arm Position
Official title: Prospective Phase II Randomized Clinical Study of the Accuracy of Multi-modal Guided Particle Radiotherapy for Postoperative Breast Cancer With Different Arm Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: immobilization positions
breast cancer
particle radiotherapy
dosimetry
multi-modal guided radiotherapy
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Primary outcomes:
measure: The accuracy of multi-modal guided particle radiotherapy for postoperative breast cancer with different immobilization position
timeFrame: within 3 months after radiotherapy
Secondary outcomes:
measure: Acute toxicities
timeFrame: within 3 months after radiotherapy
measure: Late toxicities
timeFrame: > 3 months after radiotherapy
measure: Tumor local control rate
timeFrame: at 5 years post radiotherapy
measure: Overall survival rate
timeFrame: at 5 years post radiotherapy
measure: Progression free survival rate
timeFrame: at 5 years post radiotherapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
References: