CompletedNot applicableNCT00777751
Official study title

Radiation Therapy and Cardiac Enzymes

Study summary

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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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forTumor

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 10, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 10, 2018. Always confirm current availability with the study team.

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