Fludeoxyglucose F 18 PET/CT Scans in Predicting Therapy Response in Patients With Stage IIIA Non-Small Cell Lung Cancer Undergoing Chemoradiation
NCT ID: NCT01314677
Last Updated: 2012-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-04-30
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Group A (FDG PET/CT between RT fractions 5-6)
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.
positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT
fludeoxyglucose F 18
Undergo FDG PET/CT
Group B (FDG PET/CT between RT fractions 10-11)
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.
positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT
fludeoxyglucose F 18
Undergo FDG PET/CT
Group C (FDG PET/CT between RT fractions 15-16)
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.
positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT
fludeoxyglucose F 18
Undergo FDG PET/CT
Interventions
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positron emission tomography/computed tomography (PET/CT)
Undergo FDG PET/CT
fludeoxyglucose F 18
Undergo FDG PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing or plan to undergo induction chemoradiation
Exclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Khanh Nguyen
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Countries
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Other Identifiers
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NCI-2011-00337
Identifier Type: REGISTRY
Identifier Source: secondary_id
10012
Identifier Type: -
Identifier Source: org_study_id