The Safety Management of Cardiac Toxicity in Breast Cance... | NCT02942615

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

NCT02942615

Sponsor

Ruijin Hospital

Status

Unknown status

Last Update Posted

Dec 29, 2022Actual

Enrollment

220Estimated

Phase

Not Applicable

Conditions

Breast Neoplasms
Cardiotoxicity

Interventions

limit heart dose

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 27, 2017Actual

Primary Completion Date

Oct 8, 2020Actual

Completion Date

Oct 2025Estimated

First Submitted Date

Oct 19, 2016

First Submission Date that Met QC Criteria

Oct 21, 2016

First Posted Date

Oct 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2022

Last Update Posted Date

Dec 29, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiayi Chen, Chief of department of radiation oncology, Ruijin HospitalPrincipal Investigator

Lead Sponsor

Ruijin HospitalOTHER

Collaborators

Name	Class
RenJi Hospital	OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	OTHER
Shanghai 6th People's Hospital	OTHER
Shanghai 10th People's Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heart safety management	Experimental	limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity	Other: limit heart dose
Control group	No Intervention	without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
limit heart dose	Other	limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%	Heart safety management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cardiac toxicity event free survival	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity	1 year

Secondary Outcomes

Measure	Description	Time Frame
cardiac toxicity event free survival	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity	5 years
cardiac toxicity event free survival	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital, Shanghai Jiaotong University School of Medicine		Shanghai	Shanghai Municipality	200025	China

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D066126	Cardiotoxicity

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided