Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
18 Years
N/A
Both
Lung Cancer
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Clinical stage IIB or III disease
- No small cell carcinoma
- No stage IV disease*
- No diffuse bronchoalveolar subtype
- No planned definitive surgical resection NOTE: *Patients with evidence of stage
IV disease by positron emission tomography are eligible if the evidence cannot
be confirmed by other means AND the physician still plans to proceed with
definitive chemoradiation
- Planning treatment with definitive chemoradiotherapy
- 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution
Safety Issue:
No
Principal Investigator
Mitchell Machtay, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kimmel Cancer Center (KCC)
Authority:
United States: Federal Government
Study ID:
CDR0000362061
NCT ID:
NCT00083083
Start Date:
March 2005
Completion Date:
Related Keywords:
- Lung Cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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 |
