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Study Summary
No. 2007-0489:.......Unspecified......David Grosshans......Radiation Oncology
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Study Summary Title
Study Summary
Number:		2007-0489
Study Title:Radiation Therapy and Cardiac Biomarkers
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Physician New Patient Referral
Name:David GrosshansPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-2300
Contact us about clinical trials
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General Information
Disease Group:UnspecifiedSupported By:Dr. Markman's Fund
Phase of Study:N/AReturn
Visit:		3 visits for blood draws and EKG to scheduled concurrently with RT follow-up
visits and one additional visit one month after completion of RT.
Treatment
Agents:		NoneHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		None
Description/
Intervention:		The goal of this clinical research study is to learn if the radiation that you
are receiving will result in an increase in certain proteins produced by the
heart called cardiac biomarkers.
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Study Objectives / Outcomes
Primary Endpoints
To investigate the relationship between radiation dose to the heart and cardiac biomarker levels; and to investigate the temporal relationship between RT delivery and anticipated elevation of cardiac biomarkers.

Secondary Endpoints
We will test whether the correlation between the change from baseline in the enzyme level and the heart V30 (volume of heart receiving > 30 Gy) is significantly greater than 0. We will also estimate the correlation between the change from baseline in the enzyme level and the heart V30 with a 95% confidence interval. We will perform the analysis described here for each of the 2 enzymes and each of the 3 time points (beyond baseline) described above.

We will use descriptive statistics (mean, median, quartiles) to summarize the change from baseline in the enzyme levels at each time point (beyond baseline). We will use side-by-side boxplots to illustrate the distribution of the change from baseline in the enzyme levels over time. We will use mixed effects regression with second order terms to model the change from baseline in the enzyme levels as a function of time, and we will graph the regression line for each enzyme over a scatter plot of the data.

We will tabulate the incidence of adverse cardiac outcomes including myocardial infarction, heart failure, arrhythmias, all-cause and cardiac-specific mortality at the same time points used to analyze cardiac biomarker levels (i.e., within 48 hours prior to RT, 12 to 24 hours following the first fraction, within 48 hours of the last fraction of RT, and 1 to 2 months following completion of RT)

    Future Studies
    The results of this study will provide the basis for long-term evaluation of cardiac outcomes in a larger cohort of patients receiving radiation therapy to the heart / mediastinal region.
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    Study Status Information
    Study Activation / Registration Date:10/06/2008
    IRB Review and Approval Date:07/15/2008
    Study Type:Observational
    Recruitment Status:Closed
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) A total of thirty patients will be prospectively enrolled in this study. Patients with tumors in the chest including histologically proven primary lung cancer, esophageal cancer, thymoma or mesothelioma to be treated with RT with or without concurrent chemotherapy to a final dose of >/=45 Gy will be included in this study.

    2) Patients with tumors in close proximity to the heart where the treating radiation oncologist anticipates the mean cardiac dose will exceed 20Gy.

    3) All patients must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.

    4) Age >/= 18

    5) Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]. For women of childbearing potential, a blood pregnancy test must be performed within 72 hours prior to the start of protocol treatment.
    Exclusion Criteria:1) Patients who receive 5-fluorouracil or adriamycin as part of their chemotherapy regimen.

    2) Patients with recent myocardial infarction in the past month, decompensated heart failure or myocarditis/pericarditis in the past month

    3) Patients with renal failure indicated by a serum creatinine level of >/= 2.0.

    4) Patients in the intensive care unite (ICU).

    5) Patients with systemic sepsis.

    6) Patients with acute pulmonary embolism in the past month.

    7) Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child.

    8) Inability to obtain histologic proof of malignancy.
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    Links
    Registration Number: NCT00777751
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

    Return to Clinical Trials at M.D. Anderson Cancer Center