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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02339 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 99813A | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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Slow Accruals
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies bioelectrical impedance phase angle in predicting treatment outcome in patients with extensive stage small cell lung cancer receiving first-line chemotherapy. Diagnostic procedures, such as bioelectrical impedance analysis, may help predict a patient's response to treatment for small cell lung cancer.
PRIMARY OBJECTIVES:
I. To evaluate the association between phase angle (PA) measurement and progression-free survival (PFS).
SECONDARY OBJECTIVES:
I. To evaluate the association between PA measurement and treatment-related outcomes of treatment response, adverse treatment events, and overall survival (OS).
II. To determine the feasibility of obtaining PA measurements at a single time point in patients undergoing evaluation in thoracic oncology clinics.
OUTLINE:
Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.
After completion of study treatment, patients are followed up every 2-3 months for two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (bioelectric impedance analysis) | Experimental | Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bioelectric impedance analysis | Procedure | Undergo bioelectric impedance analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Analyzed using Kaplan-Meier plots and a log-rank test to test the difference in progression-free survival and high/low phase angle measures. | From the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years |
| Standardized phase angle measure | A Cox proportional hazards model will be used. The standardized phase angle measure will be treated as a continuous measure and baseline characteristics will be included as covariates in the survival model. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response (complete, partial, progressive disease, stable disease) using the Response Evaluation Criteria in Solid Tumors (RECIST) | Logistic regression will be used to analyze the association between standardized phase angle and best overall response. | Up to 2 years |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jimmy Ruiz | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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A Cox proportional hazards model will be used. |
| From the start of treatment to date of death or date of last contact, assessed up to 2 years |
| Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | For those events that are the most common, the mean standardized phase angle for those experiencing the condition will be presented. | Up to 2 years |