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RTOG 1012 Protocol Information

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Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer - RTOG CCOP Study (open to U.S. sites only)
Protocol Documents
Current Version Date: 9/5/2013
Principal Investigator: Lawrence B. Berk, MD, PhD
Primary Objective:

Evaluate the relative efficacy of 4 times a day consumption of liquid or lozenge Manuka honey to delay or prevent radiation esophagitis-related pain (during combined chemotherapy and radiation therapy for lung cnancer) as compared to standard supportive treatment, as measured at week 4 by Numerical Rating Pain Scale (NRPS) for pain upon swallowing

NOTE: This trial is open to U.S. institutions only; see Section 5.2 of the protocol for details.

Patient Population:

Patients being treated with combination chemotherapy (definitive or adjuvant) and radiation therapy once daily for small cell or non-small cell lung cancer; at least 5 cm of the esophagus must be in the 60 Gy isodose volume

Target Accrual: 150
Current Accrual: 163
Status: Closed to Accrual
Date: 10/15/2013
Participating Sites:
21st Century Oncology Las Vegas NV
Abbott Northwestern Hospital Minneapolis MN
Abington Memorial Hospital Abington PA
Adams Cancer Center Gettysburg PA
Adena Regional Medical Center Chillicothe OH
Albert Einstein Medical Center Philadelphia PA
Allegiance Health/W.A. Foote Memorial Hospital Jackson MI
Alta Bates Summit Medical Center - Summit Campus Oakland CA
Anderson Memorial Hospital Anderson SC
Aria Health Philadelphia PA
Arizona Oncology - Deer Valley Center Phoenix AZ
Arizona Oncology Services Foundation Scottsdale AZ
Auburn Radiation Oncology Center Auburn CA
Augusta Health Cancer Center Fishersville VA
Aultman Hospital Canton OH
Barnes Jewish West County Hospital St. Louis MO
Bay Area Medical Center Marinette WI
Bay Area Tumor Institute CCOP Oakland CA
Beaumont CCOP Royal Oak MI
Benefis Healthcare-Sletten Cancer Institute Great Falls MT
Billings Clinic Cancer Center Billings MT
Bixby Medical Center Adrian MI
Boston Medical Center MBCCOP Boston MA
Bozeman Deaconess Hospital Cancer Center Bozeman MT
Bronson Battle Creek Battle Creek MI
Bryn Mawr Hospital Bryn Mawr PA
Cape Cod Hospital Hyannis MA
Carle Cancer Center CCOP Urbana IL
Carolina Medical Center-Northeast Concord NC
Carolinas Medical Center/Levine Cancer Institute Charlotte NC
Carolinas Medical Center-Union Monroe NC
CentraCare Health System/Coborn Cancer Center St. Cloud MN
Central Maine Medical Center Lewiston ME
Central Maryland Oncology at Howard County Hospital Columbia MD
Champlain Valley Physicians Hospital Medical Center Plattsburgh NY
Cherry Tree Cancer Center Hanover PA
Cheshire Medical Center Keene NH
Christiana Care Health Services, Inc. CCOP Newark DE
Clackamas Radiation Oncology Center Clackamas OR
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland OH
Cleveland Clinic Cancer Center-Independence Independence OH
Cleveland Clinic Foundation Cleveland OH
Cleveland Clinic Foundation- Parma Parma OH
Cleveland Clinic Wooster Specialty Center Wooster OH
Cleveland Clinic-Strongsville Strongsville OH
Coastal Carolina Radiation Oncology Center Wilmington NC
Columbia River CCOP Portland OR
Columbia St. Mary's Hospital Ozaukee, Inc Mequon WI
Columbia-Presbyterian Medical Center New York NY
Columbia-Saint Mary's Milwaukee Milwaukee WI
Columbus Community Clinical Oncology Program Columbus OH
Community Cancer Center Normal IL
Community Medical Center Toms River NJ
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas NV
Comprehensive Cancer Ctrs of Nevada - Henderson Henderson NV
Comprehensive Cancer Ctrs of Nevada - Northwest Las Vegas NV
Comprehensive Cancer Ctrs of Nevada - Summerlin Las Vegas NV
Comprehensive Cancer Ctrs of Nevada - Sunset Las Vegas NV
Concord Hospital Payson Center for Cancer Care Concord NH
Cooper Health System Camden NJ
Cooper Health System-Voorhees Voorhees NJ
Dartmouth Hitchcock Medical Center Lebanon NH
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Cancer Center East St. George UT
Doctor's Hospital Columbus OH
Door County Cancer Center Sturgeon Bay WI
Duke University Medical Center Durham NC
East Bay Radiation Oncology Center Castro Valley CA
Elkhart General Hospital Elkhart IN
Elliot Hospital Manchester NH
Enloe Medical Center Chico CA
Epic Care Dublin - Partners in Cancer Care Dublin CA
Epic Care Pleasant Hill - Partners in Cancer Care Pleasant Hill CA
Fairbanks Memorial Hospital Fairbanks AK
Fairview Ridges Hospital Burnsville MN
Fairview Southdale Hospital Edina MN
First Health of the Carolinas Pinehurst NC
Florida Hospital Orlando FL
Florida Radiation Oncology Group - Baptist Regional Jacksonville FL
Flower Hospital Sylvania OH
Fox Chase Virtua Health Cancer Treatment Center Voorhees NJ
Gaston Memorial Hospital Gastonia NC
Geisinger Medical Center CCOP Danville PA
Geisinger Wyoming Valley Medical Center Wilkes Barre PA
Genesis Healthcare System Zainesville OH
Genesys Regional Medical Center Flint MI
Gibbs Cancer Center-Pelham Greer SC
Good Samaritan Health Systems Kearney NE
Grady Memorial Hospital Delaware OH
Grand Rapids Clinical Oncology Program (GRCOP) Grand Rapids MI
Grant Medical Center Columbus OH
Greenville Health System Cancer Institute-Faris Greenville SC
Greenville Health System Cancer Institute-Greer Radiation Greer SC
Greenville Health System Cancer Institute-International Greenville SC
Greenville Health System Cancer Institute-Seneca Seneca SC
Greenville Health System Cancer Institute-Spartanburg Spartanburg SC
Gulf Coast MB-CCOP-Cancer Center at Providence Hospital Mobile AL
Heartland Regional Medical Center St. Joseph MO
Hematology-Oncology Associates of CNY CCOP East Syracuse NY
Hennepin County Medical Center Minneapolis MN
Henry Ford Hospital Detroit MI
High Point Regional Hospital High Point NC
Highland Hospital Rochester NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Holy Cross Hospital Inc. Fort Lauderdale FL
Holy Redeemer Hospital Meadowbrook PA
Hurley Cancer Center Flint MI
ICON – Baptist Medical Center South Jacksonville FL
ICON – Cancer Center of Putnam Palatka FL
ICON – Flagler Cancer Center St Augustine FL
ICON – Florida Cancer Center - Beaches Jacksonville Beach FL
ICON – Orange Park Cancer Center Orange Park FL
ICON – Southside Cancer Center Jacksonville FL
Idaho Urologic Institute Meridian ID
Illinois Oncology Research Association CCOP Peoria IL
Indiana University Health Ball Memorial Hospital, Inc. Muncie IN
Indiana University Health Methodist Hospital Indianapolis IN
Ingalls Memorial Hospital Harvey IL
Intermountain Medical Center Murray UT
JC Robinson, MD Regional Cancer Center San Pablo CA
Jersey Shore University Medical Center Neptune NJ
John H. Stroger, Jr. Hospital of Cook County MBCCOP Chicago IL
Jupiter Medical Center Jupiter FL
Kansas City CCOP Prairie Village KS
Kuakini Medical Center Honolulu HI
La Porte Hospital La Porte IN
Lake/University Seidman Cancer Center Mentor OH
Lakeland Regional Health System St. Joseph MI
Lankenau Hospital Wynnewood PA
LDS Hospital Salt Lake City UT
Legacy Good Samaritan Hospital & Medical Center Portland OR
Legacy Mount Hood Medical Center Gresham OR
Legacy Salmon Creek Hospital Vancouver WA
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Savannah GA
Lewis Cancer & Research Pavilion-Hilton Head/Blufton Hilton Head Island SC
Liberty Radiation Oncology Clinic Liberty MO
Licking Memorial Hospital Newark OH
Lima Memorial Hospital Lima OH
Logan Regional Hospital Logan UT
Main Line CCOP Wynnewood PA
Maine Medical Center Scarborough ME
Maplewood Cancer Center Maplewood MN
Margaret R. Pardee Memorial Hospital Hendersonville NC
Marietta Memorial Hospital Marietta OH
Marshall Radiation Oncology Center Cameron Park CA
Mayo Clinic Rochester MN
Mayo Clinic Arizona Phoenix AZ
Mayo Clinic in Arizona Scottsdale AZ
McKay-Dee Hospital Ogden UT
McLaren Cancer Institute - Flint Flint MI
McLaren Cancer Institute - Lapeer Lapeer MI
McLaren Cancer Institute - Owosso Owosso MI
MD Anderson Cancer Center Orlando Orlando FL
Medical University of Ohio Toledo OH
Memorial Hospital South Bend IN
Memorial Medical Center Savannah GA
Memorial Mission-St. Joseph`s Asheville NC
Memorial Sloan Kettering Cancer Center (MSKCC) at Phelps Sleepy Hollow NY
Memorial Sloan Kettering of Rockville Center Rockville NY
Memorial Sloan Kettering-Basking Ridge Basking Ridge NJ
Memorial Sloan-Kettering Cancer Center New York NY
Memorial Sloan-Kettering Cancer Center at Commack Commack NY
Menorah Medical Center Overland Park KS
Mercy Cancer Center Elyria OH
Mercy Cancer Center at St. Ann Toledo OH
Mercy General Radiation Oncology Center Sacramento CA
Mercy Health Partners-Johnson Family Center Muskegon MI
Mercy Hospital Coon Rapids MN
Mercy Hospital Port Huron Port Huron MI
Mercy Hospital St. Louis St Louis MO
Mercy Medical Center Canton OH
Mercy San Juan Radiation Oncology Center Carmichael CA
Metro-MN CCOP St. Louis Park MN
Michiana Hematology-Oncology, P.C. Mishawaka IN
Michigan Cancer Research Consortium CCOP Ann Arbor MI
Mid Ohio Oncology Hematology Inc- Mark H. Zangmeister Ctr Cols OH
Monmouth Medical Center Long Branch NJ
Montana Cancer Consortium CCOP Billings MT
Mount Carmel Medical Center-State Street Columbus OH
Mount Carmel-St. Ann's Cancer Center Westerville OH
Mount Clemens Regional Medical Center Mount Clemens MI
Mount Nittany Medical Center - Penn State Cancer Institute State College PA
Mount Sinai Comprehensive Cancer Center CCOP Miami Beach FL
Nevada Cancer Research Foundation CCOP Las Vegas NV
New Hanover Regional Medical Center Wilmington NC
New York Methodist Hospital Brooklyn NY
North Coast Cancer Care Sandusky OH
North Kansas City Hospital North Kansas City MO
North Memorial Medical Center Robbinsdale MN
Northeast Georgia Medical Center Gainesville GA
Northeast Radiation Oncology Center Dunmore PA
Northern Indiana Cancer Research Consortium CCOP South Bend IN
Northwest Cancer Specialists-Vancouver Vancouver WA
Oakwood Healthcare Inc Dearborn MI
Ocean Medical Center Brick NJ
Ohio State University Medical Center Columbus OH
OSF Saint Francis Medical Center Radiation Oncology Peoria IL
Paoli Memorial Hospital Paoli PA
Parkview Cancer Center - Parkview Hospital Fort Wayne IN
PeaceHealth Southwest Medical Center Vancouver WA
PeaceHealth St. Joseph Cancer Center Bellingham WA
Pekin Cancer Treatment Center Pekin IL
Penrose Cancer Center, Penrose-St. Francis Health Services Colorado Springs CO
Piedmont Fayette Hospital Fayetteville GA
Piedmont Hospital Atlanta GA
Pocono Cancer Center East Strousburg PA
Presbyterian Hospital Charlotte NC
Providence Hospital Southfield MI
Providence Portland Medical Center Portland OR
Providence St. Joseph Medical Center - Disney Family CA Ctr Burbank CA
Providence St. Vincent Medical Center Portland OR
Radiation Oncology Associates Fort Wayne IN
Radiation Oncology Centers of Las Vegas Las Vegas NV
Radiological Associates of Sacramento Sacramento CA
Rapid City Regional Hospital Rapid City SD
Regions Radiation Therapy St. Paul MN
Research Medical Center Kansas City MO
Rex Cancer Center Raleigh NC
Rice Memorial Hospital Willmar MN
Ridgeview Medical Center Waconia MN
Riverside Methodist Hospital Columbus OH
Riverview Medical Center/Riverview Regional Cancer Center Red Bank NJ
Rockingham Memorial Hospital Hahn Cancer Center Harrisonburg VA
Rocky Mountain Oncology Center Casper WY
Roseville Radiation Oncology Center Roseville CA
Saint Alphonsus Regional Medical Center Boise ID
Saint Francis Medical Center Peoria IL
Saint John's Hospital - HealthEast Maplewood MN
Saint Joseph Regional Medical Center - Mishawaka Mishawaka IN
Saint Mary's Health Care/Hospital Grand Rapids MI
Saint Vincent Mercy Medical Center Toledo OH
Seidman Cancer Center – Firelands Regional Medical Center Sandusky OH
Siteman Cancer Center - South County St Louis MO
Solano Radiation Oncology Center Vacaville CA
South Atlantic Radiation Oncology Supply NC
Southern Ohio Medical Center - Cancer Center Portsmouth OH
Sparrow Regional Cancer Center Lansing MI
Sparta Cancer Center Sparta NJ
Spartanburg Regional Medical Center Spartanburg SC
Spectrum Health-Grand Rapid Clinical Oncology Program Grand Rapids MI
Springfield Regional Medical Center Springfield OH
St Francis Hospital & Medical Center Hartford CT
St Luke's Hospital Kansas City MO
St. Anthony's Health Alton IL
St. Charles Mercy Hospital Oregon OH
St. Francis Hospital Federal Way WA
St. Johns Hospital & Medical Center Grosse Pointe Woods MI
St. Joseph Hospital Orange CA
St. Joseph Mercy Hospital Ann Arbor MI
St. Joseph Mercy Oakland Pontac MI
St. Lukes Hospital Association of Duluth Duluth MN
St. Mary Mercy Hospital Livonia MI
St. Mary`s Medical Center Saginaw MI
St. Mary's Hospital Medical Center Green Bay WI
St. Vincent Anderson Regional Hospital, Inc. Anderson IN
St. Vincent Regional Cancer Center CCOP Green Bay WI
Stanford University Medical Center Palo Alto CA
Tate Cancer Center - North Arundel Hospital Glen Burnie MD
Temple University School of Medicine Philadelphia PA
The Cancer Center of Hawaii-Leeward Ewa Beach HI
The Cancer Center of Hawaii-Liliha Honolulu HI
The Comprehensive Cancer Center at JFK Medical Center Lake Worth FL
The Kirklin Clinic at Acton Road Birmingham AL
The Medical Center, Inc., John B. Amos Cancer Center Columbus GA
The Queen's Medical Center Honolulu HI
The Regional Cancer Center at Singing River Hospital System Pascagoula MS
Thedacare Cancer Institute Appleton WI
Thomas Jefferson University Hospital Philadelphia PA
Toledo Clinic Cancer Centers - Adrian Adrian MI
Toledo Clinic Cancer Centers - Maumee Maumee OH
Toledo Community Hospital Oncology Program CCOP Toledo OH
Trinity Cancer Care Center Minot ND
UH Seidman Cancer Center at Geauga Medical Center Chardon OH
UH Seidman Cancer Center at Southwest General Middleburgh OH
UHHS - Chagrin Highlands Orange Village OH
UHHS - Westlake Medical Center Westlake OH
United Hospital St. Paul MN
Unity Hospital Fridley MN
Univ of Kansas Comprehensive Cancer Center Kansas City KS
University Hospitals of Cleveland Cleveland OH
University of Alabama at Birmingham Medical Center Birmingham AL
University of California Davis Medical Center Sacramento CA
University of California San Francisco San Francisco CA
University of Cincinnati Cincinnati OH
University of Colorado Denver Aurora CO
University of Florida Health Science Center Jacksonville FL
University of Hawaii Cancer Research Center MBCCOP Honolulu HI
University of Kansas Cancer Center - Southwest Overland Park KS
University of Kansas Cancer Center-East Lee's Summit MO
University of Kansas Cancer Center-North Kansas City MO
University of Kansas Cancer Center-South Kansas City MO
University of Kentucky Hospital Lexington KY
University of Maryland Medical Systems Baltimore MD
University of Michigan Medical Center Ann Arbor MI
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Rochester Rochester NY
University of Texas at San Antonio San Antonio TX
University of Texas Medical Branch Galveston TX
University Pointe-Precision Radiotherapy West Chester OH
Upper Delaware Valley Cancer Center Milford PA
Upstate Carolina CCOP - Gibbs Regional Cancer Center Spartanburg SC
Utah Cancer Specialists Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Veterans Affairs Medical Center Long Beach CA
Virginia Mason CCOP Seattle WA
Virtua-Memorial Hospital Burlington County, Inc. Mount Holly NJ
Wake Forest University Baptist Medical Center Winston-Salem NC
Warren Cancer Research Foundation-Oklahoma CCOP Tulsa OK
Washington University St. Louis MO
Wayne State University-Karmanos Cancer Institute Detroit MI
Webber Cancer Center Warren MI
Weisberg Cancer Treatment Center Farmington Hills MI
Welch Cancer Center Sheridan WY
Wentworth-Douglass Hospital Dover NH
William Beaumont Hospital / Troy Troy MI
York Cancer Center York PA
Zablocki VA Medical Center-Wood Milwaukee WI
Updated: 10/15/2013

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