Cardiotoxicity of Radiation Therapy (CTRT)

NCT ID: NCT02769299

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 147 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-02
• Study Completion Date: 2018-11-26

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.

Conditions

Breast Cancer; Lung Cancer; Mediastinal Lymphomas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Radiation Therapy

less than 1 Gy with protons to 4-8 Gy with photons

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bonnie Ky, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 04115

Identifier Type: -

Identifier Source: org_study_id