Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00083083
- Lead Sponsor
- American College of Radiology Imaging Network
- Brief Summary
RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (\^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment.
PURPOSE: This phase II trial is studying how well \^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer.
Secondary
* Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients.
* Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients.
* Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients.
* Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques.
OUTLINE: This is a diagnostic, multicenter study.
Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (\^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment \^18FDG-PET imaging.
Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year.
PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution
- Secondary Outcome Measures
Name Time Method Relationship of survival to post-treatment max SUV as determined by the imaging institute Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution Reliability between peak and max SUV measurements both pre- and post-treatment Proportion of participants who are either upstaged or downstaged by positron emission tomography scan Reliability between PET scan-defined response to therapy measurements Correlation of Ki-67 expression with peak and max pre-treatment SUV Association between Ki-67 expression and overall survival at 2 years
Trial Locations
- Locations (49)
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Knight Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Hospital of Saint Raphael
🇺🇸New Haven, Connecticut, United States
Rush Cancer Institute at Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
🇺🇸Sacramento, California, United States
North Broward Medical Center
🇺🇸Dearfield Beach, Florida, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Waukesha Memorial Hospital Regional Cancer Center
🇺🇸Waukesha, Wisconsin, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Brown University School of Medicine
🇺🇸Providence, Rhode Island, United States
South Shore Hospital
🇺🇸South Weymouth, Massachusetts, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Center for Cancer Care at Goshen General Hospital
🇺🇸Goshen, Indiana, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Dana-Farber Partners Cancer Care
🇺🇸Boston, Massachusetts, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Bon Secours Cancer Institute at St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
Grand River Regional Cancer Centre at Grand River Hospital
🇨🇦Kitchner, Ontario, Canada
National Cancer Center - Korea
🇰🇷Goyang, Korea, Republic of
Scottsdale Medical Imaging, Limited
🇺🇸Scottsdale, Arizona, United States
Renown Institute for Cancer at Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
🇺🇸Toms River, New Jersey, United States
Saint John's Cancer Center at Saint John's Medical Center
🇺🇸Anderson, Indiana, United States
Cleveland Clinic Cancer Center at Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Mallinckrodt Institute of Radiology at Washington University Medical Center
🇺🇸St. Louis, Missouri, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Roger Williams Medical Center
🇺🇸Providence, Rhode Island, United States
Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital
🇺🇸Boynton Beach, Florida, United States
Integrated Community Oncology Network at Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
🇺🇸Teaneck, New Jersey, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States