Prospective Study of Particle Radiotherapy for Breast Cancer With Different Arm Position

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878678
• Other study ID #: SPHIC-TR-Bca2022-03
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2023
• Source: Shanghai Proton and Heavy Ion Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PET-CT: Positron Emission Tomography - Computed Tomography CT: Computed Tomography

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 ß-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 ß-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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Fixed positions of arm down and arm up
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.

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of multi-modal guided particle radiotherapy for postoperative breast cancer with different immobilization position	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.	within 3 months after radiotherapy
Secondary	Acute toxicities	Acute toxicities assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03	within 3 months after radiotherapy
Secondary	Late toxicities	Late toxicities assessed by Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC)	> 3 months after radiotherapy
Secondary	Tumor local control rate		at 5 years post radiotherapy
Secondary	Overall survival rate		at 5 years post radiotherapy
Secondary	Progression free survival rate		at 5 years post radiotherapy