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Cardiotoxicity of Radiation Therapy (CTRT)

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ClinicalTrials.gov Identifier: NCT02769299
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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
Breast Cancer Lung Cancer Mediastinal Lymphomas Radiation: Radiation Therapy

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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: Radiation Therapy
    less than 1 Gy with protons to 4-8 Gy with photons


Primary Outcome Measures :
  1. Number of CV injury [ Time Frame: 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
breast cancer, lung cancer, and mediastinal lymphomas
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

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): NCT02769299


Locations
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United States, Pennsylvania
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
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Principal Investigator: Bonnie Ky, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02769299     History of Changes
Other Study ID Numbers: UPCC 04115
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries