Spots Global Cancer Trial Database for Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
Official Title: Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC
Study ID: NCT02186847
Study Description
Brief Summary: This randomized phase II trial studies how well chemotherapy and radiation therapy given with or without metformin hydrochloride works in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is more effective when given with or without metformin hydrochloride in treating stage III non-small cell lung cancer.
Detailed Description: PRIMARY OBJECTIVES: I. To determine whether metformin hydrochloride (MET) added to chemoradiotherapy can improve progression-free survival (PFS) in patients with locally advanced non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. Determine the effects of MET on overall survival (OS), time to local-regional progression (LRP), and time to distant metastasis (DM). II. Evaluate the effect of MET on chemoradiotherapy toxicity (Common Terminology Criteria for Adverse Events, version 4 \[CTCAE, v. 4\]) within 1 year of completion of all treatment. III. Collect biospecimens to develop biomarkers of MET activity. OUTLINE: Patients are randomized to 1 of 2 treatment arms. After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Lewis and Faye Manderson Cancer Center, Tuscaloosa, Alabama, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, United States
Eden Hospital Medical Center, Castro Valley, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Memorial Medical Center, Modesto, California, United States
Kaiser Permanente Oakland-Broadway, Oakland, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova, California, United States
Rohnert Park Cancer Center, Rohnert Park, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States
The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
South Sacramento Cancer Center, Sacramento, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Kaiser Permanente Cancer Treatment Center, South San Francisco, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central, Colorado Springs, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
UF Cancer Center at Orlando Health, Orlando, Florida, United States
21st Century Oncology-Palatka, Palatka, Florida, United States
Piedmont Hospital, Atlanta, Georgia, United States
John B Amos Cancer Center, Columbus, Georgia, United States
Dekalb Medical Center, Decatur, Georgia, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
The Cancer Center of Hawaii-Pali Momi, 'Aiea, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Kootenai Cancer Center, Post Falls, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls, Idaho, United States
Northwest Community Hospital, Arlington Heights, Illinois, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
IU Health Bloomington, Bloomington, Indiana, United States
Radiation Oncology Associates PC, Fort Wayne, Indiana, United States
Parkview Hospital Randallia, Fort Wayne, Indiana, United States
Franciscan Health Indianapolis, Indianapolis, Indiana, United States
Mercy Hospital, Cedar Rapids, Iowa, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
Wesley Medical Center, Wichita, Kansas, United States
Hardin Memorial Hospital, Elizabethtown, Kentucky, United States
Baptist Health Lexington, Lexington, Kentucky, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
LSU Health Baton Rouge-North Clinic, Baton Rouge, Louisiana, United States
Louisiana Hematology Oncology Associates LLC, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Our Lady of the Lake Physicians Group - Medical Oncology, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Covington, Covington, Louisiana, United States
Mary Bird Perkins Cancer Center - Houma, Houma, Louisiana, United States
Maine Medical Center- Scarborough Campus, Scarborough, Maine, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
UM Upper Chesapeake Medical Center, Bel Air, Maryland, United States
UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie, Maryland, United States
Peninsula Regional Medical Center, Salisbury, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Lowell General Hospital, Lowell, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
McLaren Cancer Institute-Flint, Flint, Michigan, United States
Mercy Health Saint Mary's, Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
McLaren Cancer Institute-Lapeer Region, Lapeer, Michigan, United States
McLaren Cancer Institute-Macomb, Mount Clemens, Michigan, United States
McLaren Cancer Institute-Central Michigan, Mount Pleasant, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
McLaren Cancer Institute-Owosso, Owosso, Michigan, United States
McLaren Cancer Institute-Northern Michigan, Petoskey, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
Lakeland Medical Center Saint Joseph, Saint Joseph, Michigan, United States
William Beaumont Hospital - Troy, Troy, Michigan, United States
Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Saint Luke's Hospital of Duluth, Duluth, Minnesota, United States
Fairview-Southdale Hospital, Edina, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
North Kansas City Hospital, Kansas City, Missouri, United States
The University of Kansas Cancer Center-South, Kansas City, Missouri, United States
The University of Kansas Cancer Center-North, Kansas City, Missouri, United States
The University of Kansas Cancer Center-Lee's Summit, Lee's Summit, Missouri, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
CHI Health Saint Francis, Grand Island, Nebraska, United States
CHI Health Good Samaritan, Kearney, Nebraska, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Wentworth-Douglass Hospital, Dover, New Hampshire, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Virtua Memorial, Mount Holly, New Jersey, United States
Community Medical Center, Toms River, New Jersey, United States
Virtua Voorhees, Voorhees, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
New Mexico Oncology Hematology Consultants, Albuquerque, New Mexico, United States
New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn, New York, United States
University of Rochester, Rochester, New York, United States
Gaston Hematology and Oncology Associates-Belmont, Belmont, North Carolina, United States
CaroMont Regional Medical Center, Gastonia, North Carolina, United States
Gaston Hematology and Oncology Associates, Gastonia, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
UHHS-Chagrin Highlands Medical Center, Beachwood, Ohio, United States
Mercy Medical Center, Canton, Ohio, United States
Aultman Health Foundation, Canton, Ohio, United States
Geauga Hospital, Chardon, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
University of Cincinnati/Barrett Cancer Center, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
The Mark H Zangmeister Center, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Good Samaritan Hospital - Dayton, Dayton, Ohio, United States
Mercy Cancer Center-Elyria, Elyria, Ohio, United States
Cleveland Clinic Cancer Center Independence, Independence, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights, Ohio, United States
Newark Radiation Oncology, Newark, Ohio, United States
University Hospitals Parma Medical Center, Parma, Ohio, United States
Southern Ohio Medical Center, Portsmouth, Ohio, United States
North Coast Cancer Care, Sandusky, Ohio, United States
UH Seidman Cancer Center at Firelands Regional Medical Center, Sandusky, Ohio, United States
Cleveland Clinic Cancer Center Strongsville, Strongsville, Ohio, United States
University Pointe, West Chester, Ohio, United States
UHHS-Westlake Medical Center, Westlake, Ohio, United States
Cleveland Clinic Wooster Family Health and Surgery Center, Wooster, Ohio, United States
Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Northeast Radiation Oncology Center, Dunmore, Pennsylvania, United States
The Regional Cancer Center, Erie, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania, United States
Reading Hospital, West Reading, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Lankenau Medical Center, Wynnewood, Pennsylvania, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States
Saint Francis Cancer Center, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States
Self Regional Healthcare, Greenwood, South Carolina, United States
Greenville Health System Cancer Institute-Greer, Greer, South Carolina, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca, Seneca, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
University of Texas Medical Branch, Galveston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
The Methodist Hospital System, Houston, Texas, United States
MD Anderson in Katy, Houston, Texas, United States
UTMB Cancer Center at Victory Lakes, League City, Texas, United States
MD Anderson League City, Nassau Bay, Texas, United States
MD Anderson in Sugar Land, Sugar Land, Texas, United States
MD Anderson in The Woodlands, The Woodlands, Texas, United States
Intermountain Medical Center, Murray, Utah, United States
Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, United States
University of Vermont Medical Center, Burlington, Vermont, United States
Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont, United States
Augusta Health Center for Cancer and Blood Disorders, Fishersville, Virginia, United States
Harrison Medical Center, Bremerton, Washington, United States
PeaceHealth Saint John Medical Center, Longview, Washington, United States
PeaceHealth Southwest Medical Center, Vancouver, Washington, United States
Wheeling Hospital/Schiffler Cancer Center, Wheeling, West Virginia, United States
Aurora Cancer Care-Grafton, Grafton, Wisconsin, United States
Aurora BayCare Medical Center, Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Community Memorial Hospital, Menomonee Falls, Wisconsin, United States
Ascension Columbia Saint Mary's Hospital Ozaukee, Mequon, Wisconsin, United States
Ascension Columbia Saint Mary's Water Tower Medical Commons, Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Zablocki Veterans Administration Medical Center, Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Saint Michael's Hospital, Stevens Point, Wisconsin, United States
Aurora Medical Center in Summit, Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
The Alyce and Elmore Kraemer Cancer Care Center, West Bend, Wisconsin, United States
Diagnostic and Treatment Center, Weston, Wisconsin, United States
Aspirus UW Cancer Center, Wisconsin Rapids, Wisconsin, United States
Jewish General Hospital, Montreal, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Chaim Sheba Medical Center, Tel Hashomer, , Israel
Contact Details
Name: Theodoros Tsakiridis
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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