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Sponsors and Collaborators: |
American College of Radiology Imaging Network National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00424138 |
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.
Condition | Intervention |
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Lung Cancer |
Drug: fludeoxyglucose F 18 Procedure: chemotherapy Procedure: computed tomography Procedure: positron emission tomography |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer |
Estimated Enrollment: | 285 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a prospective, multicenter study. Patients are assigned to 1 of 3 groups.
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.
Biomarker
PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Newly diagnosed stage IIIB (with malignant pleural effusion) or stage IV disease, determined by all of the following:
Patients with recurrent or metastatic disease are eligible provided they meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-1781 | |
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 |
Study Chair: | Wolfgang Weber, MD | Jonsson Comprehensive Cancer Center |
Investigator: | Denise R. Aberle, MD | Jonsson Comprehensive Cancer Center |
Investigator: | Barry A. Siegel, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Investigator: | Anthony F. Shields, MD, PhD | Barbara Ann Karmanos Cancer Institute |
Investigator: | Karen Rickard, MD | Jonsson Comprehensive Cancer Center |
Investigator: | Steven M. Dubinett, MD | Jonsson Comprehensive Cancer Center |
Investigator: | Joel Karp, PhD | University of Pennsylvania |
Study ID Numbers: | CDR0000527084, ACRIN-6678 |
Study First Received: | January 16, 2007 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00424138 |
Health Authority: | Unspecified |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |