Cardiotoxicity of Radiation Therapy (CTRT) | NCT02769299

Studies
Cardiotoxicity of Radiation Therapy (CTRT)

NCT02769299

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Completed

Last Update Posted

Jan 9, 2019Actual

Enrollment

147Actual

Phase

Not provided

Conditions

Breast Cancer
Lung Cancer
Mediastinal Lymphomas

Interventions

Radiation Therapy

Countries

United States

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2015Actual

Primary Completion Date

Nov 26, 2018Actual

Completion Date

Nov 26, 2018Actual

First Submitted Date

May 9, 2016

First Submission Date that Met QC Criteria

May 10, 2016

First Posted Date

May 11, 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

Jan 8, 2019

Last Update Posted Date

Jan 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The overall objective of this proposal is to determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart. We will focus specifically on patients receiving photon or proton chest radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury, as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

147Actual

Name	Type	Description	Arm Group Labels	Other Names
Radiation Therapy	Radiation	less than 1 Gy with protons to 4-8 Gy with photons

Measure	Description	Time Frame
Number of CV injury		8 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older.
Patients with left sided breast cancer newly initiating fractionated whole breast/chest wall with regional nodal photon or proton radiation therapy.
Patients with right sided breast cancer with newly initiating fractionated photon or proton radiation therapy with mediastinal nodal proton or photon radiation therapy that will include cardiac dose.
Lung cancer patients treated with definitive intent (greater than or equal to 50 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. Patients receiving concurrent chemotherapy will be allowed.
Patients with mediastinal lymphoma, whose lowest extent of mediastinal disease is at or below the level of the carina, treated with consolidative radiation with definitive intent (greater than or equal to 20 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy.
Ability to read and comprehend English.

Exclusion Criteria:

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Patients receiving stereotactic body radiotherapy
Patients unable to undergo MR imaging will be excluded from the optional MR, but will not be excluded from the main study.
Life expectancy less than 12 months
Vulnerable patients as noted in 5 below (children, pregnant women, fetuses, neonates, or prisoners)
Patients with estimated glomerular filtration rate of less than 60 ml/min/1.73sq.m will be excluded from the optional MR, but will not be excluded from the main study.
Non-diagnostic echocardiography windows

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

breast cancer, lung cancer, and mediastinal lymphomas

Sampling Method

Probability Sample

ID	Term
D001943	Breast Neoplasms
D008175	Lung Neoplasms

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