Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
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.
Interventional
Masking: Open Label, Primary Purpose: Diagnostic
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution
No
Mitchell Machtay, MD
Study Chair
Kimmel Cancer Center (KCC)
United States: Federal Government
CDR0000362061
NCT00083083
March 2005
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Roger Williams Medical Center | Providence, Rhode Island 02908-4735 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Tallahassee Memorial Hospital | Tallahassee, Florida 32308 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Bon Secours Cancer Institute at St. Mary's Hospital | Richmond, Virginia 23226 |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |
Hospital of Saint Raphael | New Haven, Connecticut 06511 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Rush Cancer Institute at Rush University Medical Center | Chicago, Illinois 60612 |
Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
South Shore Hospital | South Weymouth, Massachusetts 02190 |
Mallinckrodt Institute of Radiology at Washington University Medical Center | St. Louis, Missouri 63110 |
Brown University School of Medicine | Providence, Rhode Island 02905 |
Saint John's Cancer Center at Saint John's Medical Center | Anderson, Indiana 46016 |
Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |
North Broward Medical Center | Dearfield Beach, Florida 33064-3596 |
Scottsdale Medical Imaging, Limited | Scottsdale, Arizona 85262 |
Radiological Associates of Sacramento Medical Group at Sutter Cancer Center | Sacramento, California 95816 |
Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital | Boynton Beach, Florida 33435 |
Integrated Community Oncology Network at Baptist Cancer Institute | Jacksonville, Florida 32207 |
Dana-Farber Partners Cancer Care | Boston, Massachusetts 02129 |
Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital | Teaneck, New Jersey 07666 |