Clinical trial · Observational

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

NCT01627080CI-TRIAL-00015223withdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Cardiac Biomarker Blood Draws	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Cardiac Biomarkers
description
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.
interventionNames
1. Other: Cardiac Biomarker Blood Draws

Primary outcomes (1)

measure
Evaluation of Cardiac Biomarker Elevation with Radiation Therapy
timeFrame
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).
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.

Secondary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.