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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942615
Recruitment Status : Unknown
Verified January 2019 by Jiayi Chen, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : October 24, 2016
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai 6th People's Hospital
Shanghai 10th People's Hospital
Information provided by (Responsible Party):
Jiayi Chen, Ruijin Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Cardiotoxicity Other: limit heart dose Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Randomized Multi-center Phase III Study About the Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Heart safety management
limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity
 Other: limit heart dose
limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%
Other Names:
  • frequently follow of cardiac function
  • management of cardiotoxicity
No Intervention: Control group
without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity


Outcome Measures
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Primary Outcome Measures :
  1. cardiac toxicity event free survival [ Time Frame: 1 year ]
    The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity


Secondary Outcome Measures :
  1. cardiac toxicity event free survival [ Time Frame: 5 years ]
    The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity

  2. cardiac toxicity event free survival [ Time Frame: 10 years ]
    The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity

  3. overall survival [ Time Frame: 5 years ]
    The time from the date of randomization to the date of death from any cause

  4. overall survival [ Time Frame: 10 years ]
    The time from the date of randomization to the date of death from any cause

  5. relative change of value of serum cardiac biomarkers of creatine kinase (CK)-MB [ Time Frame: 1 year ]
    The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

  6. relative change of value of serum cardiac biomarkers of Cardiac troponin (cTn)-I [ Time Frame: 1 year ]
    The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

  7. relative change of value of serum cardiac biomarkers of N-terminal pro brain natriuretic peptide (NT-proBNP) [ Time Frame: 1 year ]
    The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

  8. relative change of value of serum cardiac biomarkers of CK-MB [ Time Frame: 5 years ]
    The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

  9. relative change of value of serum cardiac biomarkers of cTn-I [ Time Frame: 5 years ]
    The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

  10. relative change of value of serum cardiac biomarkers of NT-proBNP [ Time Frame: 5 years ]
    The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

  11. relative change of left ventricular ejection fraction (LVEF) [ Time Frame: 1 year ]
    The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

  12. relative change of LVEF [ Time Frame: 5 year ]
    The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapyThe change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

  13. relative change of LVEF [ Time Frame: 10 year ]
    The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

  14. Quality of Life-EORTC QLQ-C30 [ Time Frame: 1 year ]
    Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30

  15. Quality of Life-EORTC QLQ-BR23 [ Time Frame: 1 year ]
    Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23

  16. Quality of Life-EORTC QLQ-C30 [ Time Frame: 5 years ]
    Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30

  17. Quality of Life-EORTC QLQ-BR23 [ Time Frame: 5 years ]
    Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942615


Contacts
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Contact: Jia-Yi Chen, M.D. +86-021-64370045 ext 602400 chenjiayi0188@aliyun.com

Locations
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China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Jia-Yi Chen, M.D.    +86-021-64370045 ext 602400    chenjiayi0188@aliyun.com   
Contact: Jia-Yi Chen, M.D    +86-021-64370045 ext 602400    chenjiayi0188@aliyun.com   
Sponsors and Collaborators
Ruijin Hospital
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai 6th People's Hospital
Shanghai 10th People's Hospital
More Information
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Responsible Party: Jiayi Chen, Chief of department of radiation oncology, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02942615    
Other Study ID Numbers: Cardio-RT
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries