170
Participants
Start Date
August 31, 2014
Primary Completion Date
April 16, 2019
Study Completion Date
September 4, 2025
Radiation Therapy
Radiation therapy (RT) is given in 2 Gy fractions once daily 5 days per week to a total of 30 fractions and 60 Gy. Photons required; 3-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) permitted. Starts within 14 days of randomization (Chemoradiation arm) or 14 days after metformin starts (Chemoradiation + Metformin arm).
Carboplatin
2 AUC (area under the curve) via IV weekly on days 1, 8, 15, 22, 29, and 36 from start of radiation therapy. Two 21 day cycles of 6 AUC via IV starting 28-42 days after the end of radiation therapy.
Metformin
Metformin is taken orally. Dose escalation begins 2 weeks prior to the initiation of chemoradiation. 500 mg twice daily days 1-7 of metformin. 500 mg three times daily days 8-14 of metformin. Three times a day with the following dosage: 500mg in the morning, 1000mg at noon, and 500mg in the evening concurrent with chemoradiation and through consolidation chemotherapy (days 15-126 of metformin),
Paclitaxel
50 mg/m2 via IV weekly on days 1, 8, 15, 22, 29, and 36 from start of radiation therapy. Two 21 day cycles of 200 mg/m2 via IV 28-42 days after the end of radiation therapy.
New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn
University of Rochester, Rochester
UPMC-Shadyside Hospital, Pittsburgh
The Regional Cancer Center, Erie
Geisinger Medical Center, Danville
Northeast Radiation Oncology Center, Dunmore
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
Abington Memorial Hospital, Abington
Lankenau Medical Center, Wynnewood
Thomas Jefferson University Hospital, Philadelphia
Reading Hospital, West Reading
Christiana Care Health System-Christiana Hospital, Newark
UM Upper Chesapeake Medical Center, Bel Air
UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie
University of Maryland/Greenebaum Cancer Center, Baltimore
Peninsula Regional Medical Center, Salisbury
Augusta Health Center for Cancer and Blood Disorders, Fishersville
Wheeling Hospital/Schiffler Cancer Center, Wheeling
Gaston Hematology and Oncology Associates-Belmont, Belmont
CaroMont Regional Medical Center, Gastonia
Gaston Hematology and Oncology Associates, Gastonia
FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst
Spartanburg Medical Center, Spartanburg
Greenville Health System Cancer Institute-Spartanburg, Spartanburg
Greenville Health System Cancer Institute-Faris, Greenville
Saint Francis Cancer Center, Greenville
Greenville Health System Cancer Institute-Eastside, Greenville
AnMed Health Cancer Center, Anderson
Self Regional Healthcare, Greenwood
Greenville Health System Cancer Institute-Greer, Greer
Gibbs Cancer Center-Pelham, Greer
Greenville Health System Cancer Institute-Seneca, Seneca
Dekalb Medical Center, Decatur
Piedmont Hospital, Atlanta
Memorial Health University Medical Center, Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah
John B Amos Cancer Center, Columbus
21st Century Oncology-Palatka, Palatka
UF Cancer Center at Orlando Health, Orlando
Lewis and Faye Manderson Cancer Center, Tuscaloosa
University of Mississippi Medical Center, Jackson
Baptist Health Lexington, Lexington
University of Kentucky/Markey Cancer Center, Lexington
Hardin Memorial Hospital, Elizabethtown
Newark Radiation Oncology, Newark
Ohio State University Comprehensive Cancer Center, Columbus
Riverside Methodist Hospital, Columbus
The Mark H Zangmeister Center, Columbus
Mount Carmel Health Center West, Columbus
Genesis Healthcare System Cancer Care Center, Zanesville
Geauga Hospital, Chardon
Mercy Cancer Center-Elyria, Elyria
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor
Case Western Reserve University, Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland
UHHS-Chagrin Highlands Medical Center, Beachwood
Hillcrest Hospital Cancer Center, Mayfield Heights
University Hospitals Parma Medical Center, Parma
UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights
Cleveland Clinic Cancer Center Independence, Independence
Cleveland Clinic Cancer Center Strongsville, Strongsville
UHHS-Westlake Medical Center, Westlake
Cleveland Clinic Foundation, Cleveland
Cleveland Clinic Wooster Family Health and Surgery Center, Wooster
Mercy Medical Center, Canton
Aultman Health Foundation, Canton
North Coast Cancer Care, Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center, Sandusky
University Pointe, West Chester
University of Cincinnati/Barrett Cancer Center, Cincinnati
Good Samaritan Hospital - Dayton, Dayton
Kettering Medical Center, Kettering
Adena Regional Medical Center, Chillicothe
Southern Ohio Medical Center, Portsmouth
Franciscan Health Indianapolis, Indianapolis
Radiation Oncology Associates PC, Fort Wayne
Parkview Hospital Randallia, Fort Wayne
IU Health Bloomington, Bloomington
McLaren Cancer Institute-Macomb, Mount Clemens
William Beaumont Hospital-Royal Oak, Royal Oak
William Beaumont Hospital - Troy, Troy
Henry Ford Hospital, Detroit
Saint Joseph Mercy Oakland, Pontiac
McLaren Cancer Institute-Lapeer Region, Lapeer
McLaren Cancer Institute-Flint, Flint
McLaren Cancer Institute-Central Michigan, Mount Pleasant
McLaren Cancer Institute-Owosso, Owosso
West Michigan Cancer Center, Kalamazoo
Lakeland Medical Center Saint Joseph, Saint Joseph
Mercy Health Mercy Campus, Muskegon
Mercy Health Saint Mary's, Grand Rapids
Spectrum Health at Butterworth Campus, Grand Rapids
McLaren Cancer Institute-Northern Michigan, Petoskey
Mercy Hospital, Cedar Rapids
Chaim Sheba Medical Center, Tel Litwinsky
Aurora Cancer Care-Grafton, Grafton
Community Memorial Hospital, Menomonee Falls
Aurora Medical Center in Summit, Summit
The Alyce and Elmore Kraemer Cancer Care Center, West Bend
Ascension Columbia Saint Mary's Hospital Ozaukee, Mequon
Aurora Cancer Care-Kenosha South, Kenosha
Ascension Columbia Saint Mary's Water Tower Medical Commons, Milwaukee
Aurora Saint Luke's Medical Center, Milwaukee
Medical College of Wisconsin, Milwaukee
Aurora West Allis Medical Center, West Allis
Zablocki Veterans Administration Medical Center, Milwaukee
Cancer Center of Western Wisconsin, New Richmond
Bay Area Medical Center, Marinette
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers
Aurora BayCare Medical Center, Green Bay
Marshfield Medical Center-Marshfield, Marshfield
Diagnostic and Treatment Center, Weston
Saint Michael's Hospital, Stevens Point
Aspirus UW Cancer Center, Wisconsin Rapids
Marshfield Clinic-Minocqua Center, Minocqua
Marshfield Medical Center-Rice Lake, Rice Lake
Regions Hospital, Saint Paul
United Hospital, Saint Paul
Abbott-Northwestern Hospital, Minneapolis
Hennepin County Medical Center, Minneapolis
Mercy Hospital, Coon Rapids
Fairview-Southdale Hospital, Edina
Saint Luke's Hospital of Duluth, Duluth
Rice Memorial Hospital, Willmar
Sanford Joe Lueken Cancer Center, Bemidji
Sanford Roger Maris Cancer Center, Fargo
Sanford Bismarck Medical Center, Bismarck
Billings Clinic Cancer Center, Billings
Community Medical Hospital, Missoula
Northwest Community Hospital, Arlington Heights
John H Stroger Jr Hospital of Cook County, Chicago
Rush University Medical Center, Chicago
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin
OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria
Methodist Medical Center of Illinois, Peoria
OSF Saint Francis Medical Center, Peoria
Carle Cancer Center, Urbana
Decatur Memorial Hospital, Decatur
Memorial Medical Center, Springfield
Good Samaritan Regional Health Center, Mount Vernon
Missouri Baptist Medical Center, St Louis
Mercy Hospital Saint Louis, St Louis
Saint Francis Medical Center, Cape Girardeau
Southeast Cancer Center, Cape Girardeau
The University of Kansas Cancer Center-Lee's Summit, Lee's Summit
North Kansas City Hospital, Kansas City
The University of Kansas Cancer Center-South, Kansas City
The University of Kansas Cancer Center-North, Kansas City
Delbert Day Cancer Institute at PCRMC, Rolla
CoxHealth South Hospital, Springfield
Lawrence Memorial Hospital, Lawrence
University of Kansas Cancer Center, Kansas City
University of Kansas Cancer Center-Overland Park, Overland Park
Ascension Via Christi Hospitals Wichita, Wichita
Wesley Medical Center, Wichita
Nebraska Methodist Hospital, Omaha
University of Nebraska Medical Center, Omaha
CHI Health Saint Francis, Grand Island
CHI Health Good Samaritan, Kearney
Mary Bird Perkins Cancer Center - Houma, Houma
Mary Bird Perkins Cancer Center - Covington, Covington
LSU Health Baton Rouge-North Clinic, Baton Rouge
Louisiana Hematology Oncology Associates LLC, Baton Rouge
Mary Bird Perkins Cancer Center, Baton Rouge
Our Lady of the Lake Physicians Group - Medical Oncology, Baton Rouge
University of Oklahoma Health Sciences Center, Oklahoma City
M D Anderson Cancer Center, Houston
The Methodist Hospital System, Houston
MD Anderson League City, Nassau Bay
MD Anderson in Katy, Houston
MD Anderson in The Woodlands, The Woodlands
MD Anderson in Sugar Land, Sugar Land
UTMB Cancer Center at Victory Lakes, League City
SCL Health Lutheran Medical Center, Wheat Ridge
University of Colorado Hospital, Aurora
Swedish Medical Center, Englewood
McKee Medical Center, Loveland
North Colorado Medical Center, Greeley
Penrose-Saint Francis Healthcare, Colorado Springs
UCHealth Memorial Hospital Central, Colorado Springs
Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls
Saint Alphonsus Cancer Care Center-Boise, Boise
Kootenai Cancer Center, Post Falls
Intermountain Medical Center, Murray
Banner University Medical Center - Tucson, Tucson
University of New Mexico Cancer Center, Albuquerque
New Mexico Oncology Hematology Consultants, Albuquerque
UC San Diego Moores Cancer Center, La Jolla
Kaiser Permanente Cancer Treatment Center, South San Francisco
UCSF Medical Center-Mount Zion, San Francisco
Eden Hospital Medical Center, Castro Valley
Kaiser Permanente Oakland-Broadway, Oakland
Rohnert Park Cancer Center, Rohnert Park
Memorial Medical Center, Modesto
Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville
Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova
The Permanente Medical Group-Roseville Radiation Oncology, Roseville
Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville
Sutter Medical Center Sacramento, Sacramento
South Sacramento Cancer Center, Sacramento
The Cancer Center of Hawaii-Pali Momi, ‘Aiea
Queen's Medical Center, Honolulu
The Cancer Center of Hawaii-Liliha, Honolulu
Harrison Medical Center, Bremerton
PeaceHealth Saint John Medical Center, Longview
PeaceHealth Southwest Medical Center, Vancouver
Maine Medical Center- Scarborough Campus, Scarborough
Boston Medical Center, Boston
Lowell General Hospital, Lowell
Wentworth-Douglass Hospital, Dover
Dartmouth Hitchcock Medical Center, Lebanon
Virtua Memorial, Mount Holly
Community Medical Center, Toms River
Virtua Voorhees, Voorhees Township
Sanford USD Medical Center - Sioux Falls, Sioux Falls
University of Texas Medical Branch, Galveston
Central Vermont Medical Center/National Life Cancer Treatment, Berlin Corners
University of Vermont Medical Center, Burlington
Norris Cotton Cancer Center-North, Saint Johnsbury
Jewish General Hospital, Montreal
Allan Blair Cancer Centre, Regina
Saskatoon Cancer Centre, Saskatoon
Lead Sponsor
National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER