Cardiotoxicity of Radiation Therapy (CTRT)

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02769299
• Collaborator: (none)
• Enrollment: 147
• Location: 1
• Actual Duration (Months): 41.8
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Lung Cancer; Mediastinal Lymphomas	Radiation: Radiation Therapy

Study Design

• Study Type: Observational
• Actual Enrollment: 147 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cardiotoxicity of Radiation Therapy (CTRT)
• Actual Study Start Date: Jun 2, 2015
• Actual Primary Completion Date: Nov 26, 2018
• Actual Study Completion Date: Nov 26, 2018

Outcome Measures

Primary Outcome Measures

1. Number of CV injury [8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Bonnie Ky, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02769299
• Other Study ID Numbers: UPCC 04115
• First Posted: May 11, 2016
• Last Update Posted: Jan 9, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Cardiotoxicity

Study Results

No Results Posted as of Jan 9, 2019