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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fixed positions of arm down and arm up
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring immobilization positions, breast cancer, particle radiotherapy, dosimetry, multi-modal guided radiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fixed positions of arm up

Fixed positions of arm down

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acute toxicities
Acute toxicities assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
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)
Tumor local control rate
Overall survival rate
Progression free survival rate

Full Information

First Posted
April 30, 2023
Last Updated
May 18, 2023
Sponsor
Shanghai Proton and Heavy Ion Center
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1. Study Identification

Unique Protocol Identification Number
NCT05878678
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
immobilization positions, breast cancer, particle radiotherapy, dosimetry, multi-modal guided radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fixed positions of arm up
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fixed positions of arm down
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fixed positions of arm down and arm up
Intervention 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.
Primary Outcome Measure Information:
Title
The accuracy of multi-modal guided particle radiotherapy for postoperative breast cancer with different immobilization position
Description
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.
Time Frame
within 3 months after radiotherapy
Secondary Outcome Measure Information:
Title
Acute toxicities
Description
Acute toxicities assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Time Frame
within 3 months after radiotherapy
Title
Late toxicities
Description
Late toxicities assessed by Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC)
Time Frame
> 3 months after radiotherapy
Title
Tumor local control rate
Time Frame
at 5 years post radiotherapy
Title
Overall survival rate
Time Frame
at 5 years post radiotherapy
Title
Progression free survival rate
Time Frame
at 5 years post radiotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201321
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfang Zhao
Phone
+86 021-38296666
Email
jingfang.zhao@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Ping Li
Phone
+86 021-38296666
Email
ping.li@sphic.org.cn

12. IPD Sharing Statement

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

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