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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00337 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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No subjects have been accrued to this trial. The PI will no longer be at COH and requests a study withdrawal/closure.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help doctors predict a patient's response to treatment and help plan the best treatment
PRIMARY OBJECTIVES:
I. To determine whether early response of the research positron emission tomography (PET)-computed tomography(CT) scan measured by change in Standard Uptake Value (SUV)max relative to baseline scan can predict induction chemoradiation therapy (CRT) failures sooner than post-treatment PET-CT scan.
II. To determine the optimal timing for 18FDG PET-CT that best predicts for induction CRT failure.
SECONDARY OBJECTIVES:
I. To correlate early 18 fludeoxyglucose (FDG) PET-CT response metrics with pathologic response, progression-free survival separately for: induction CRT failures vs. non-failures, or overall survival separately for induction CRT failures vs. non-failures.
OUTLINE: Patients are randomized to 1 of 3 groups.
Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.
GROUP A: Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy).
GROUP B: Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy).
GROUP C: Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy).
Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (FDG PET/CT between RT fractions 5-6) | Experimental | Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy. Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy). Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. |
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| Group B (FDG PET/CT between RT fractions 10-11) | Experimental | Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy. Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy). Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. |
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| Group C (FDG PET/CT between RT fractions 15-16) | Experimental | Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy. Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy). Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| positron emission tomography/computed tomography (PET/CT) | Procedure | Undergo FDG PET/CT |
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| Measure | Description | Time Frame |
|---|---|---|
| Induction therapy failure | Defined as any evidence by clinically unresectable disease based on tumor board consensus and review of restaging scans demonstrating locoregional progression or distant metastasis, surgically unresectable disease based on surgical exploration, or suboptimal resection disease still requiring pneumonectomy and still having R1 resection. | 6 weeks after completion of chemoradiation therapy (CRT) |
| Early positron emission tomography (PET) response of group A | Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point. | Baseline and between standard radiotherapy (RT) fractions 5-6 |
| Early positron emission tomography (PET) response of group B | Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point. | Baseline and between standard radiotherapy (RT) fractions 10-11 |
| Early positron emission tomography (PET) response of group C | Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point. | Baseline and between standard radiotherapy (RT) fractions 15-16 |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic response | 6 weeks after completion of chemoradiation therapy (CRT) | |
| Progression-free survival | Every 3 months for 2 years and every 6 months thereafter | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khanh Nguyen | City of Hope Medical Center | Principal Investigator |
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| fludeoxyglucose F 18 | Radiation | Undergo FDG PET/CT |
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| Overall survival |
| Every 3 months for 2 years and every 6 months thereafter |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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