Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00083083
Last Updated: 2011-03-01
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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UNKNOWN
PHASE2
250 participants
INTERVENTIONAL
2005-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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DIAGNOSTIC
NONE
Interventions
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carboplatin
cisplatin
docetaxel
etoposide
paclitaxel
vinblastine sulfate
vinorelbine tartrate
gene expression analysis
positron emission tomography
fludeoxyglucose F 18
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy
* Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy
* No brain metastases by head CT scan or MRI
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy)
* Able to tolerate positron emission tomography imaging
* No poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL)
* No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy
Chemotherapy
* See Disease Characteristics
* No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior thoracic radiotherapy
* No concurrent intensity-modulated radiotherapy
Surgery
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
American College of Radiology Imaging Network
NETWORK
Responsible Party
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Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Principal Investigators
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Mitchell Machtay, MD
Role: STUDY_CHAIR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Locations
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Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States
Scottsdale Medical Imaging, Limited
Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
Sacramento, California, United States
Hospital of Saint Raphael
New Haven, Connecticut, United States
Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital
Boynton Beach, Florida, United States
North Broward Medical Center
Dearfield Beach, Florida, United States
Integrated Community Oncology Network at Baptist Cancer Institute
Jacksonville, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber Partners Cancer Care
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
South Shore Hospital
South Weymouth, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Mallinckrodt Institute of Radiology at Washington University Medical Center
St Louis, Missouri, United States
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
Teaneck, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
Brown University School of Medicine
Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 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
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, 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, , South Korea
Countries
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Other Identifiers
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ACRIN-6668
Identifier Type: -
Identifier Source: secondary_id
RTOG-0235
Identifier Type: -
Identifier Source: secondary_id
CDR0000362061
Identifier Type: -
Identifier Source: org_study_id
NCT00194389
Identifier Type: -
Identifier Source: nct_alias
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