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The Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.

NCT ID: NCT02942615

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-27

Study Completion Date

2025-10-31

Brief Summary

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This trial is to explore the optimal strategies for guaranteeing the cardiac safety of breast cancer patients following adjuvant radiotherapy in the modern era of multidisciplinary treatment.

Detailed Description

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With the development of modern radiotherapy techniques, the dose-volume of heart irradiated could be kept in much low level. However, until now, the optimal dose-volume parameters for limiting heart irradiation, the optimal follow-up interval for cardiac safety after adjuvant radiotherapy, the optimal screening examinations and treatments for irradiation-induced cardiac toxicity are unclear. We designed this trial to find answer for above questions to establish rationalization proposal for prevention, treatment and follow-up for cardiac toxicity associated with adjuvant radiotherapy for breast cancer.

Conditions

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Breast Neoplasms Cardiotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Heart safety management

limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity

Group Type EXPERIMENTAL

limit heart dose

Intervention Type OTHER

limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%

Control group

without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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limit heart dose

limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%

Intervention Type OTHER

Other Intervention Names

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frequently follow of cardiac function management of cardiotoxicity

Eligibility Criteria

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Inclusion Criteria

* Patients willing to participate the research and sign the informed consent file;
* Patients aged 18-80 years;
* KPS≥70;
* Pathological diagnosis for invasive breast cancer;
* Patients received anthracycline/paclitaxel based chemotherapy, or herceptin based targeted therapy;
* No functional heart disease;
* LVEF≥50%;
* Patients received breast conserving surgery;
* Patients received modified radical mastectomy: T1-2 with N1-3 or T3-4 with any N;
* Tumor margin negative;
* No metastases;
* No other malignant tumor history.

Exclusion Criteria

* Patients with metastases;
* Tumor margin positive;
* Patients received modified radical mastectomy with T1-2 and N0;
* Patients have other malignant tumor;
* Patients have a history of heart disease;
* Patients received chest radiotherapy previously;
* Patients with severe organic and functional disease;
* Unqualified patients with sufficient reasons;
* Cannot or no willing to sign the informed consent file;
* Patients with autoimmune disease;
* Women with pregnancy, planned pregnancy or lactating.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiayi Chen

Chief of department of radiation oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Cardio-RT

Identifier Type: -

Identifier Source: org_study_id