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
points:
- 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
Follow-Up:
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
performed:
- 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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Evaluation of Cardiac Biomarker Elevation with Radiation Therapy
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.
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).
No
Steven H. Lin, MD,PHD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2012-0004
NCT01627080
May 2013
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |