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

January 11, 2023 updated by: Qing Zhang,MD, Shanghai Proton and Heavy Ion Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adjuvant hypofractionated intensity-modulated proton radiotherapy
CTV1: chest wall ± regional lymph drainage area, proton therapy.
Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy
CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the failure rate of breast reconstruction after hypofractionated proton radiotherapy
Time Frame: within 2 years after hypofractionated proton radiotherapy
Reoperation
within 2 years after hypofractionated proton radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute and late toxicities
Time Frame: within 5 years after radiotherapy
Treatment related toxicity assessed by CTCAE v4.03
within 5 years after radiotherapy
Tumor local control rate, overall survival rate and progression free survival rate
Time Frame: within 5 years after radiotherapy
The Ipsilateral breast and regional lymph nodes recurrence, death and progression
within 5 years after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Proton and Heavy Ion Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 10, 2023

Primary Completion (Anticipated)

September 1, 2028

Study Completion (Anticipated)

September 1, 2028

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPHIC-TR-BCa2022-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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