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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01627080
First received: June 21, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The goal of this clinical research study is to learn if the radiation that you will receive for esophageal cancer may cause the heart to create more proteins called cardiac biomarkers.

When cardiac biomarkers are above normal levels, there may be heart damage. The relationship between cardiac biomarkers and radiation therapy has not been well studied. Learning more about this relationship may lead to better ways to check the heart during radiation therapy and predict heart problems.


Condition Intervention
Esophageal Cancer
Other: Cardiac Biomarker Blood Draws

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Evaluation of Cardiac Biomarker Elevation with Radiation Therapy [ 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). ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of Adverse Cardiac Outcomes [ 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). ] [ Designated as safety issue: No ]
    Incidence of adverse cardiac outcomes tabulated including myocardial infarction, heart failure, arrhythmias, all-cause and cardiac-specific mortality at same time points used to analyze cardiac biomarker levels.


Biospecimen Retention:   Samples With DNA

Blood draws include troponin I, NT-proBNP, and BNP.


Enrollment: 0
Study Start Date: April 2014
Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cardiac Biomarkers
Patients with histologically proven esophageal cancer to be treated with radiation therapy with concurrent chemotherapy to a final dose of >/=40 Gy included in this study at UT MD Anderson Cancer Center in Houston, Texas.
Other: Cardiac Biomarker Blood Draws
Blood (about 1 teaspoon) 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, and about 1 to 2 months after completion of radiation therapy.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with histologically proven esophageal cancer to be treated with radiation therapy with concurrent chemotherapy to a final dose of >/=40 Gy included in this study at UT MD Anderson Cancer Center in Houston, Texas.

Criteria

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 treatment.
  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 mL/min/1.73sq.m.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627080

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Steven H. Lin, MD,PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01627080     History of Changes
Other Study ID Numbers: 2012-0004
Study First Received: June 21, 2012
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Esophagus
Esophageal Cancer
Radiation therapy
RT
Chemotherapy
Mid thoracic tumor
Distal esophageal tumor
Gastroesophageal junction tumor
Cardiac biomarkers

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 28, 2014