Fludeoxyglucose F 18 PET/CT Scans in Predicting Therapy Response in Patients With Stage IIIA Non-Small Cell Lung Cancer Undergoing Chemoradiation

City of Hope

Status: Withdrawn

Conditions: Stage IIIA Non-small Cell Lung Cancer

Treatments: Procedure: positron emission tomography/computed tomography (PET/CT); Radiation: fludeoxyglucose F 18

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01314677

10012 (Registry Identifier)

NCI-2011-00337 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with marginally resectable IIIA (N2) NSCLC undergoing induction CRT will be eligible for this imaging trial; patients will be screened by the chest tumor board for entry
• Undergoing or plan to undergo induction chemoradiation

Exclusion criteria

• Poorly controlled or uncontrolled diabetes mellitus, with blood glucose > 200 mg/dl
• Have allergies or medical contra-indications to FDG or intravenous (IV) contrast
• Medical contra-indications to obtaining CT or PET scans
• Pre-authorization denial of coverage by insurance providers of clinical staging and restaging PET-CT scans

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Group A (FDG PET/CT between RT fractions 5-6)

Experimental group

Description:

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.

Treatment:

Radiation: fludeoxyglucose F 18

Procedure: positron emission tomography/computed tomography (PET/CT)

Group B (FDG PET/CT between RT fractions 10-11)

Experimental group

Description:

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.

Treatment:

Radiation: fludeoxyglucose F 18

Procedure: positron emission tomography/computed tomography (PET/CT)

Group C (FDG PET/CT between RT fractions 15-16)

Experimental group

Description:

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.

Treatment:

Radiation: fludeoxyglucose F 18

Procedure: positron emission tomography/computed tomography (PET/CT)