Cardiotoxicity of Radiation Therapy (CTRT)

Breast Cancer Clinical Trial

Official title:

Cardiotoxicity of Radiation Therapy (CTRT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769299
• Other study ID #: UPCC 04115
• Status: Completed
• Start date: June 2, 2015
• Est. completion date: November 26, 2018

Study information

• Verified date: January 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: November 26, 2018
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cardiotoxicity
• Lung Cancer
• Mediastinal Lymphomas

Intervention

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

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CV injury		8 months