FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy (ACRIN 6678)
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET)/CT scans, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying ^18FDG PET/CT scans to see how well they predict response in patients undergoing chemotherapy for stage IIIB or stage IV non-small cell lung cancer.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||[18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer|
- Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy [ Time Frame: One year ]
- Correlation of metabolic response after the first course of chemotherapy with subsequent best tumor response as measured by RECIST criteria [ Time Frame: 1st Course Chemotherapy ]
- Correlation of metabolic response after the first course of chemotherapy with progression-free survival [ Time Frame: 1st Course of Chemotherapy ]
- Predictive value of fludeoxyglucose F 18 positron emission tomography (FDG-PET) for 1-year overall survival after the first and second course of chemotherapy [ Time Frame: One year ]
- Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans [ Time Frame: Within 7 Days ]
|Study Start Date:||March 2007|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: Group A - 3 FDG-PET/CT Scans
Two FDG-PET/CT scans prior to 1st cycle of chemotherapy, plus 2 optional volumetric CT scans. One FDG-PET/CT after 1st cycle of chemotherapy, plus 1 optional volumetric CT scan.
|Drug: chemotherapy Radiation: fludeoxyglucose F 18|
Experimental: Group B - 2 FDG-PET/CT Scans + 1 Optional
One FDG-PET/CT prior to 1st cycle of chemotherapy; 1 FDG-PET/CT after the 1st cycle of chemotherapy; 1 optional FDG-PET/CT after the 2nd cycle of chemotherapy. All three with optional volumetric CT scans.
|Drug: chemotherapy Radiation: fludeoxyglucose F 18|
Experimental: Group C - 2 FDG-PET/CT Test-Retest
Test-retest sequence for FDG-PET/CT; two scans with optional volumetric CT to be completed prior to 1st cycle of chemotherapy.
|Radiation: fludeoxyglucose F 18|
- Determine whether a metabolic response, defined as a 25% decrease in peak tumor standardized uptake value (SUV) after the first course of chemotherapy, provides early prediction of treatment outcome (tumor response and patient survival) in patients with stage IIIB or IV non-small cell lung cancer undergoing platinum-based chemotherapy.
- Determine the test-retest reproducibility of quantitative assessment of tumor fludeoxyglucose F 18 (^18FDG) uptake in these patients.
- Determine the time course of treatment-induced changes in tumor ^18FDG uptake in these patients.
- Determine, in an exploratory analysis, changes in tumor volume during chemotherapy by multislice CT scanning in these patients.
OUTLINE: This is a prospective, multicenter study. Patients are assigned to 1 of 3 groups.
- Group I: Patients undergo fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET)/CT scanning twice and 1-2 volumetric CT scanning (1-7 days apart) before starting treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG PET/CT scan and a volumetric CT scan once between the first and second course of chemotherapy.
- Group II: Patients undergo ^18FDG PET/CT scan and volumetric CT scanning once before starting treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG PET/CT scan and volumetric CT scanning once between the first and second course of chemotherapy, and may undergo once between the second and third course of chemotherapy.
- Group III: Patients undergo ^18FDG PET/CT scanning twice (up to 1 week apart) before starting any treatment.
In groups I and II, patients also undergo standard follow-up CT scanning every 6 weeks (i.e., every other chemotherapy course) for up to 18 weeks.
After completion of chemotherapy, patients are followed every 3 months for up to 1 year.
- Imaging: See
- provided by American College of Radiology Network.
PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424138
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Wolfgang Weber, MD||Jonsson Comprehensive Cancer Center|
|Study Chair:||Denise R. Aberle, MD||Jonsson Comprehensive Cancer Center|
|Study Chair:||Barry A. Siegel, MD||Washington University Siteman Cancer Center|
|Study Chair:||Anthony F. Shields, MD, PhD||Barbara Ann Karmanos Cancer Institute|
|Study Chair:||Karen Rickard||City of Hope Comprehensive Cancer Center|
|Study Chair:||Ramaswamy Govindan, MD||Washington University Siteman Cancer Center|
|Study Chair:||Steven M. Dubinett, MD||Jonsson Comprehensive Cancer Center|
|Study Chair:||Joel Karp, PhD||Abramson Cancer Center of the University of Pennsylvania|