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

NCT05878678 | Unknown Phase 2

• 1 other identifier: SPHIC-TR-Bca2022-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

immobilization positions; breast cancer; particle radiotherapy; dosimetry; multi-modal guided radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Acute toxicities

  within 3 months after radiotherapy

• Late toxicities

  > 3 months after radiotherapy

• Tumor local control rate

  at 5 years post radiotherapy

• Overall survival rate

  at 5 years post radiotherapy

• Progression free survival rate

  at 5 years post radiotherapy

Study Arms (2)

Fixed positions of arm up

ACTIVE COMPARATOR

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.

Device: Fixed positions of arm down and arm up

Fixed positions of arm down

EXPERIMENTAL

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.

Device: Fixed positions of arm down and arm up

Interventions

Fixed positions of arm down and arm up 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; Fixed positions of arm up

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathologically (cytological or histological) confirmed breast cancer with positive lymph nodes and postoperative adjuvant radiotherapy
• Exclude distant metastasis
• No ipsilateral breast and breast radiation therapy
• Exclude patients requiring axillary irradiation
• Age 18-80 years old
• General good health (Eastern Cooperative Oncology Group, ECOG 0-2)
• No complications such as severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, or severe chronic heart disease that may affect radiotherapy.
• Non-pregnant (confirmed by serum or urine β-HCG test) or lactating women
• Patients must sign informed consent to receive radiotherapy.

You may not qualify if:

• Pathology unapproved breast cancer
• With distant metastasis
• The ipsilateral breast or breast has received radiation therapy
• Patients requiring axillary irradiation
• The dose limit of organs at risk cannot reach the preset safe dose limit
• Pregnancy (confirmed by serum or urine β-HCG test) or lactation
• Poor general health, Karnofsky Performance Status (KPS)\<70，or ECOG\>2
• 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
• Unable to understand the purpose of treatment or unwilling to sign the treatment consent

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: May 26, 2023
• Study Start: May 15, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

CN (1)