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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:
Abington Memorial Hospital Abington PA
Adams Cancer Center Gettysburg PA
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
Augusta Health Cancer Center Fishersville VA
Aultman Hospital Canton OH
Bay Area Tumor Institute CCOP Oakland CA
Beaumont CCOP Royal Oak MI
Boston Medical Center MBCCOP Boston MA
Bronson Battle Creek Battle Creek MI
Cancer Centers of the Carolinas-Faris Road Greenville SC
Cancer Centers of the Carolinas-Greer Radiation Oncology Greer SC
Cancer Centers of the Carolinas-Seneca Seneca SC
Cancer Centers of the Carolinas-Spartanburg Spartanburg SC
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
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
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
Cooper Health System Camden NJ
Cooper Health System-Voorhees Voorhees NJ
East Bay Radiation Oncology Center Castro Valley CA
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
Florida Hospital Orlando FL
Florida Radiation Oncology Group - Baptist Regional Jacksonville FL
Genesys Regional Medical Center Flint MI
Good Samaritan Health Systems Kearney NE
Grand Rapids Clinical Oncology Program (GRCOP) Grand Rapids MI
Greenville CCOP - Cancer Centers of the Carolinas-Eastside Greenville SC
Heartland Regional Medical Center St. Joseph MO
Hematology-Oncology Associates of CNY CCOP East Syracuse NY
High Point Regional Hospital High Point NC
Hillcrest Hospital Cancer Center Mayfield Heights OH
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
Indiana University Health Methodist Hospital Indianapolis IN
Ingalls Memorial Hospital Harvey IL
JC Robinson, MD Regional Cancer Center San Pablo CA
John H. Stroger, Jr. Hospital of Cook County MBCCOP Chicago IL
Kansas City CCOP Prairie Village KS
Kuakini Medical Center Honolulu HI
Lake/University Seidman Cancer Center Mentor OH
Legacy Good Samaritan Hospital & Medical Center Portland OR
Legacy Mount Hood Medical Center Gresham OR
Legacy Salmon Creek Hospital Vancouver WA
Liberty Radiation Oncology Clinic Liberty MO
Maine Medical Center Scarborough ME
Margaret R. Pardee Memorial Hospital Hendersonville NC
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 Health Partners-Johnson Family Center Muskegon MI
Mercy Hospital Port Huron Port Huron MI
Michigan Cancer Research Consortium CCOP Ann Arbor MI
Mount Nittany Medical Center - Penn State Cancer Institute State College PA
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
Northeast Georgia Medical Center Gainesville GA
Northeast Radiation Oncology Center Dunmore PA
Northwest Cancer Specialists-Vancouver Vancouver WA
Oakwood Healthcare Inc Dearborn MI
Ohio State University Medical Center Columbus OH
PeaceHealth Southwest Medical Center Vancouver WA
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
Research Medical Center Kansas City MO
Rex Cancer Center Raleigh NC
Rockingham Memorial Hospital Hahn Cancer Center Harrisonburg VA
Saint Alphonsus Regional Medical Center Boise ID
Saint Mary's Health Care/Hospital Grand Rapids MI
Seidman Cancer Center – Firelands Regional Medical Center Sandusky OH
South Atlantic Radiation Oncology Supply NC
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
St Francis Hospital & Medical Center Hartford CT
St Luke's Hospital Kansas City MO
St. Francis Hospital Federal Way WA
St. Johns Hospital & Medical Center Grosse Pointe Woods MI
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. Vincent Anderson Regional Hospital, Inc. Anderson IN
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 Medical Center, Inc., John B. Amos Cancer Center Columbus GA
The Queen's Medical Center Honolulu HI
Thedacare Cancer Institute Appleton WI
Thomas Jefferson University Hospital Philadelphia PA
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
Univ of Kansas Comprehensive Cancer Center Kansas City KS
University Hospitals of Cleveland Cleveland OH
University of California San Francisco San Francisco CA
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 Maryland Medical Systems Baltimore MD
University of Michigan Medical Center Ann Arbor MI
University of Texas at San Antonio San Antonio TX
Upper Delaware Valley Cancer Center Milford PA
Upstate Carolina CCOP - Gibbs Regional Cancer Center Spartanburg SC
Valley Medical Oncology Consultants Pleasanton CA
Veterans Affairs Medical Center Long Beach CA
Virginia Mason CCOP Seattle WA
Warren Cancer Research Foundation-Oklahoma CCOP Tulsa OK
Wayne State University-Karmanos Cancer Institute Detroit MI
Webber Cancer Center Warren MI
Weisberg Cancer Treatment Center Farmington Hills MI
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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