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Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation

18 Years
Not Enrolling
Esophageal Cancer

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Trial Information

Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation

If you are found to be eligible and you agree to take part in this study, you will have
baseline tests. The following tests and procedures will be performed within 1-2 weeks from
the start of radiation:

- You will be asked about any other health problems you may have.

- Your performance status will be recorded.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers.

- You will have an electrocardiogram (ECG) to check your heart function.

- If the study doctor thinks it is needed, you will have an exam by a cardiologist (a
doctor who diagnoses and treats heart problems) who will check the results of your ECG.

Study Visits:

Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers at the following time

- Within 12-24 hours of the start of radiation

- One (1) time during the third week of radiation

- Within 48 hours after completion of radiation


About 1 to 2 months after you complete radiation therapy, depending on when you and your
doctor decide, you will return to the clinic. The following tests and procedures will be

- Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers.

- You will have an ECG.

Length of Study Participation:

You will be off study after your follow-up visit.

You will no longer be able to take part in the study if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Using cardiac biomarkers to check the heart during
radiation therapy to predict future heart problems is considered investigational.

Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients with histologically proven esophageal cancer to be treated with RT with
concurrent chemotherapy to a final dose of >/=40 Gy will be included in this study.

2. Patients with mid thoracic, distal esophageal, and gastroesophageal junction tumors.

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

6. Induction chemotherapy allowed.

7. Being able to meet radiation dose constraints of at-risk organs.

Exclusion Criteria:

1. Patients who receive cardiotoxic drugs, such as trastuzumab 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 glomerular filtration rate (GFR) < 30

4. Patients in the intensive care unit (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.

9. Patients with proximal / cervical esophageal cancer.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluation of Cardiac Biomarker Elevation with Radiation Therapy

Outcome Description:

Descriptive statistics used to summarize change from baseline in enzyme levels at each time point (beyond baseline). Each enzyme examined separately. Pearson or Spearman correlation coefficient used to examine correlation between changes in cardiac biomarkers from baseline in enzyme level at each time point and mean radiotherapy dose or cumulative dose to heart. Linear mixed effects regression model used to model longitudinal change in cardiac biomarker from baseline as a function of cumulative radiation to the heart, radiation modality (Protons vs Photons), and time.

Outcome Time Frame:

Within 24 hours after first fraction of radiation therapy (RT), during 3rd week of RT (fraction 11-15), within 48 hours of RT completion (fraction 26-28).

Safety Issue:


Principal Investigator

Steven H. Lin, MD,PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Esophagus
  • Esophageal Cancer
  • Radiation therapy
  • RT
  • Chemotherapy
  • Mid thoracic tumor
  • Distal esophageal tumor
  • Gastroesophageal junction tumor
  • Cardiac biomarkers
  • Esophageal Diseases
  • Esophageal Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030