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A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
adjuvant hypofractionated intensity-modulated proton radiotherapy
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 breast cancer, hypofractionated, proton radiotherapy, implantation reconstruction, postoperative adjuvant radiotherapy

Eligibility Criteria

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

Inclusion Criteria: 1: Patients with pathologically confirmed breast cancer 2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction 3: No distant metastasis 4: Had no chest and breast radiotherapy history 5: Between the ages of 18 and 80 6: ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy 7: Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women 8: The patient must sign the informed consent form for receiving radiotherapy. Exclusion Criteria: 1: No pathological confirmation; 2: Distant metastasis; 3: Had chest and breast radiotherapy history 4: Organs at risk could not achieve safe dose 5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women 6: Poor general health status, i.e. KPS<70, or ECOG>2 7: There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months; b) Acute bacterial or systemic fungal infection;c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization; d) Patients with immunosuppression;e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy; 8: Unable to understand the purpose of treatment or unwilling/unable to sign informed consent.

Sites / Locations

  • Shanghai Proton and Heavy Ion centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adjuvant hypofractionated intensity-modulated proton radiotherapy

Arm Description

CTV1: chest wall ± regional lymph drainage area, proton therapy.

Outcomes

Primary Outcome Measures

the failure rate of breast reconstruction after hypofractionated proton radiotherapy
Reoperation

Secondary Outcome Measures

Acute and late toxicities
Treatment related toxicity assessed by CTCAE v4.03
Tumor local control rate, overall survival rate and progression free survival rate
The Ipsilateral breast and regional lymph nodes recurrence, death and progression

Full Information

First Posted
January 11, 2023
Last Updated
January 11, 2023
Sponsor
Shanghai Proton and Heavy Ion Center
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1. Study Identification

Unique Protocol Identification Number
NCT05692674
Brief Title
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
Official Title
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Anticipated)
Primary Completion Date
September 1, 2028 (Anticipated)
Study Completion Date
September 1, 2028 (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 incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast cancer can significantly reduce the radiation dose of the ipsilateral heart and lung, thereby reducing the incidence of cardiac events and radiation pneumonia. This study is aimed at the study of adjuvant hypofractionated intensity-modulated proton radiotherapy for post operative breast cancer with implantation reconstruction. It can provide an ideal treatment option for such patients to effectively protect the heart and lungs without increasing the failure rate of breast reconstruction after adjuvant radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, hypofractionated, proton radiotherapy, implantation reconstruction, postoperative adjuvant radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
adjuvant hypofractionated intensity-modulated proton radiotherapy
Arm Type
Experimental
Arm Description
CTV1: chest wall ± regional lymph drainage area, proton therapy.
Intervention Type
Radiation
Intervention Name(s)
adjuvant hypofractionated intensity-modulated proton radiotherapy
Intervention Description
CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;
Primary Outcome Measure Information:
Title
the failure rate of breast reconstruction after hypofractionated proton radiotherapy
Description
Reoperation
Time Frame
within 2 years after hypofractionated proton radiotherapy
Secondary Outcome Measure Information:
Title
Acute and late toxicities
Description
Treatment related toxicity assessed by CTCAE v4.03
Time Frame
within 5 years after radiotherapy
Title
Tumor local control rate, overall survival rate and progression free survival rate
Description
The Ipsilateral breast and regional lymph nodes recurrence, death and progression
Time Frame
within 5 years after 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: 1: Patients with pathologically confirmed breast cancer 2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction 3: No distant metastasis 4: Had no chest and breast radiotherapy history 5: Between the ages of 18 and 80 6: ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy 7: Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women 8: The patient must sign the informed consent form for receiving radiotherapy. Exclusion Criteria: 1: No pathological confirmation; 2: Distant metastasis; 3: Had chest and breast radiotherapy history 4: Organs at risk could not achieve safe dose 5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women 6: Poor general health status, i.e. KPS<70, or ECOG>2 7: There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months; b) Acute bacterial or systemic fungal infection;c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization; d) Patients with immunosuppression;e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy; 8: Unable to understand the purpose of treatment or unwilling/unable to sign informed 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
Ping Li
Phone
+86 021-38296666
Email
ping.li@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Cihang Bao
Phone
+86 021-38296666
Email
cihang.Bao@sphic.org.cn

12. IPD Sharing Statement

Learn more about this trial

A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction

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