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

NCT ID: NCT05878678

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-07-30

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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fixed positions of arm up

Patients will receive particle radiotherapy in arm up position. Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy; For patients received modified radical mastectomy, Clinical Target Volume (CTV) 1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy; For patients received lumpectomy, CTV1: whole breast ± regional lymph drainage area, 40.05 Gy (RBE) in 15 fractions with proton radiotherapy; CTVtb: tumor bed SIB（simultaneous integrated boost） to 48 Gy (RBE) in 15 fractions with proton radiotherapy.

Group Type: ACTIVE_COMPARATOR

Fixed positions of arm down and arm up

Intervention Type: DEVICE

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.

Fixed positions of arm down

Patients will receive particle radiotherapy in arm down position. Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy; For patients received modified radical mastectomy, CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy; For patients received lumpectomy, CTV1: whole breast ± regional lymph drainage area, 40.05 Gy (RBE) in 15 fractions with proton radiotherapy; CTVtb: tumor bed SIB to 48 Gy (RBE) in 15 fractions with proton radiotherapy.

Group Type: EXPERIMENTAL

Fixed positions of arm down and arm up

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role: lead

Responsible Party

Qing Zhang,MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jingfang Zhao

Role: primary

jingfang.zhao@sphic.org.cn

+86 021-38296666

Ping Li

Role: backup

ping.li@sphic.org.cn

+86 021-38296666

Other Identifiers

SPHIC-TR-Bca2022-03

Identifier Type: -

Identifier Source: org_study_id