| ID | Type | Description | Link |
|---|---|---|---|
| ACRIN-6668 | |||
| RTOG-0235 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Radiation Therapy Oncology Group | NETWORK |
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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| cisplatin | Drug | |||
| docetaxel | Drug | |||
| etoposide | Drug | |||
| paclitaxel | Drug | |||
| vinblastine sulfate | Drug | |||
| vinorelbine tartrate | Drug | |||
| gene expression analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
Planning treatment with definitive chemoradiotherapy
No brain metastases by head CT scan or MRI
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Machtay, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42291584 | Derived | Zhang J, Hu Y, Tian C, Zhang X, Bian Y. Development of a Prognostic Predictive Model for Stage III Non-Small Cell Lung Cancer using PET-CT Radiomics Based on Multi-Center and Heterogeneous Data and External Validation. Pak J Med Sci. 2026 May;42(5):1214-1221. doi: 10.12669/pjms.42.5.14183. |
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| Genetic |
| positron emission tomography | Procedure |
| fludeoxyglucose F 18 | Radiation |
| radiation therapy | Radiation |
| 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 |
| Scottsdale Medical Imaging, Limited |
| Scottsdale |
| Arizona |
| 85262 |
| United States |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90089-9181 | United States |
| Radiological Associates of Sacramento Medical Group at Sutter Cancer Center | Sacramento | California | 95816 | United States |
| Hospital of Saint Raphael | New Haven | Connecticut | 06511 | United States |
| Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital | Boynton Beach | Florida | 33435 | United States |
| North Broward Medical Center | Dearfield Beach | Florida | 33064-3596 | United States |
| Integrated Community Oncology Network at Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| Rush Cancer Institute at Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Saint John's Cancer Center at Saint John's Medical Center | Anderson | Indiana | 46016 | United States |
| Center for Cancer Care at Goshen General Hospital | Goshen | Indiana | 46526 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Dana-Farber Partners Cancer Care | Boston | Massachusetts | 02129 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| South Shore Hospital | South Weymouth | Massachusetts | 02190 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| Mallinckrodt Institute of Radiology at Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Renown Institute for Cancer at Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River | New Jersey | 08755 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44302 | United States |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| UPMC Cancer Centers | Pittsburgh | Pennsylvania | 15232 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Roger Williams Medical Center | Providence | Rhode Island | 02908-4735 | United States |
| Brown University School of Medicine | Providence | Rhode Island | 02912 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | United States |
| Bon Secours Cancer Institute at St. Mary's Hospital | Richmond | Virginia | 23226 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin | 53188 | United States |
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Grand River Regional Cancer Centre at Grand River Hospital | Kitchner | Ontario | N2G 1G3 | Canada |
| National Cancer Center - Korea | Goyang | 410-769 | South Korea |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D005047 | Etoposide |
| D017239 | Paclitaxel |
| D014747 | Vinblastine |
| D000077235 | Vinorelbine |
| D020869 | Gene Expression Profiling |
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D013812 | Therapeutics |
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