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RTOG 9801 Protocol Information

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A Phase III Study of Amifostine Mucosal Protection For Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Sequential Induction and Concurrent Hyperfractionated Radiotherapy With Paclitaxel and Carbopl
Protocol Documents
Current Version Date: 2/16/2005
Principal Investigator: Benjamin Movsas, M.D.
Primary Objective:

To evaluate whether the addition of the radioprotector amifostine can reduce the incidence and severity of non-hematologic toxicity, specifically esophagitis and pneumonitis during concurrent hyperfractionated RT and chemotherapy (with paclitaxel and carboplatin).

Patient Population:
  • Medically inoperable stages II & IIIA or unresectable stages IIIA & IIIB non‐small cell lung cancer.
  • KPS > 70, age > 18
  • Weight loss < 5% in 3 months prior to diagnosis
  • No distant metastasis, prior chemo‐ or thoracic or neck radiation therapy
  • Serum creatinine < 1.5, Hgb > 8.0, absolute granulocyte count (AGC) > 2000, platelets > 100,000, Bilirubin 1.5 mg/dl; SGOT < 1.5 x institutional upper limit
  • No recurrent disease or prior complete tumor resection
  • No prior invasive malignancy unless > 3 years and currently disease‐free
  • Study‐specific consent form
  • Patients with pleural effusion (on chest xray) appearing only after thoracotomy or other invasive thoracic procedure are eligible
  • Ineligible for RTOG 93‐09 (refer to Eligibility checklist [Q20] and Section 3.1.9)
Target Accrual: 244
Current Accrual: 243
Status: Terminated
Date: 6/30/2010
Participating Sites:
21st Century Oncology Ft. Myers FL
Advocate Good Shepherd Hospital Barrington IL
Advocate Lutheran General Hospital Park Ridge IL
Albany Medical Center Albany NY
Allegiance Health Jackson MI
AMITA Health Alexian Brothers Medical Center Elk Grove Village IL
Arizona Oncology Services Foundation Scottsdale AZ
Atlanta Regional CCOP Atlanta GA
Baptist Cancer Institute Jacksonville FL
Baptist Cancer Institute CCOP Memphis TN
Baptist Health Lexington Lexington KY
Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville KY
Baptist Hospital of East Tennessee Knoxville TN
Bay Area Tumor Institute Oakland CA
Bay Medical Center Panama City FL
Beaumont Hospital - Dearborn Dearborn MI
Bon Secours Saint Mary's Hospital Richmond VA
Cancer Treatment Center Wooster OH
Caritas Regional Cancer Center Louisville KY
Christiana Care Health System-Christiana Hospital Newark DE
Clarkson Hospital Omaha NE
Cleveland Clinic Akron General Akron OH
Cleveland Clinic Foundation Cleveland OH
Clifton Springs Hospital and Clinic Clifton Springs NY
Columbia Saint Mary's Water Tower Medical Commons Milwaukee WI
Community Medical Center Toms River NJ
Community Memorial Hospital Menomonee Falls WI
Cooper Hospital University Medical Center Camden NJ
Cottonwood Hospital Medical Center Murray UT
Cross Cancer Institute Edmonton, Alberta
Dixie Medical Center Regional Cancer Center East St. George UT
East Carolina University Greenville NC
Einstein Medical Center Philadelphia Philadelphia PA
Elizabeth General Medical Center Elizabeth NJ
Emory University Hospital Midtown Atlanta GA
Emory University Hospital/Winship Cancer Institute Atlanta GA
Finley Hospital Dubuque IA
Fox Chase Cancer Center Philadelphia PA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Genesys Hurley Cancer Institute Flint MI
Grady Health System Atlanta GA
Greater Baltimore Medical Center Baltimore MD
Greenville Health System Cancer Institute-Eastside Greenville SC
Gulf Coast Cancer Treatment Center Panama City FL
Gundersen Lutheran Medical Center La Crosse WI
Halifax Health Medical Center-Centers for Oncology Daytona Beach FL
Harbin Clinic Rome GA
Harbor Hospital Center Baltimore MD
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Holmes Regional Medical Center Melbourne FL
Holy Family Memorial Hospital Manitowoc WI
Huntsman Cancer Institute/University of Utah Salt Lake City UT
Hurley Medical Center Flint MI
Indiana University Health Ball Memorial Hospital, Inc. Muncie IN
Indiana University Health Methodist Hospital Indianapolis IN
Ingalls Memorial Hospital Harvey IL
Inspira Medical Center Vineland Vineland NJ
John Muir Medical Center-Walnut Creek Concord CA
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore MD
Julie and Ben Rogers Cancer Institute Beaumont TX
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Lake Huron Medical Center Port Huron MI
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York NY
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Lewis and Faye Manderson Cancer Center Tuscaloosa AL
Liberty Hospital Liberty MO
Louisiana State University Health Science Center New Orleans LA
M D Anderson Cancer Center Houston TX
Mainline Health CCOP Wynnewood PA
McKay-Dee Hospital Center Ogden UT
Mercy Catholic Medical Center - Fitzgerald Darby PA
Methodist Hospital Philadelphia PA
Methodist Medical Center of Illinois Peoria IL
Miami Cancer Institute Miami FL
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Mid-Michigan Medical Center - Midland Midland MI
Mobile Infirmary Medical Center Mobile AL
Montana Cancer Consortium CCOP Billings MT
Montgomery Cancer Center, LLC Montgomery AL
Mount Sinai West New York NY
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa OK
Naval Medical Center - Portsmouth Portsmouth VA
Nevada Cancer Research Foundation CCOP Las Vegas NV
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn NY
Newark Beth Israel Medical Center Newark NJ
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima WA
Northern Indiana Cancer Research Consortium South Bend IN
Northridge Hospital Medical Center Northridge CA
Northwest Community Clinical Oncology Program Tacoma WA
Ochsner Medical Center Jefferson New Orleans LA
Peninsula Regional Medical Center Salisbury MD
Pocono Medical Center East Strousburg PA
Providence Alaska Medical Center Anchorage AK
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank CA
Providence St. Joseph Medical Center - Disney Family CA Ctr Burbank CA
Radiation Oncology Associates of W. Alabama PC Tuscaloosa AL
Radiation Oncology Center Alliance OH
Radiological Associates of Sacramento Sacramento CA
Rapid City Regional Hospital Rapid City SD
Regional Hospital of Scranton Scranton PA
Saint Agnes Medical Center Fresno CA
Saint Francis Medical Center Trenton NJ
Saint John Hospital and Medical Center Grosse Pointe Woods MI
Saint John Macomb-Oakland Hospital Warren MI
Saint Joseph Mercy Hospital Ann Arbor MI
Saint Joseph Regional Medical Center-Mishawaka Mishawaka IN
Saint Louis University Hospital St. Louis MO
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Mary Mercy Hospital Livonia MI
Saint Mary's of Michigan Saginaw MI
Saint Vincent Anderson Regional Hospital/Cancer Center Anderson IN
Santa Rosa Memorial Hospital CCOP Santa Rosa CA
South Georgia Medical Center/Pearlman Cancer Center Valdosta GA
Southeast Cancer Control Consortium CCOP Winston Salem NC
Southwestern Vermont Medical Center Bennington VT
Sparrow Hospital Lansing MI
St Mary Regional Cancer Center Langhorne PA
State University of New York Downstate Medical Center Brooklyn NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Swedish Medical Center-First Hill Seattle WA
The Cancer Center for Southern Kentucky Bowling Green KY
The Christ Hospital Cincinnati OH
The Don and Sybil Harrington Cancer Center Amarillo TX
The Toledo Hospital/Toledo Children's Hospital Toledo OH
Thomas Jefferson University Hospital Philadelphia PA
Toledo Community Hospital Oncology Program CCOP Toledo OH
Tom Baker Cancer Centre Calgary, Alberta
Trinity Cancer Care Center Minot ND
UCLA / Jonsson Comprehensive Cancer Center Los Angeles CA
UF Cancer Center at Orlando Health Orlando FL
UH Seidman Cancer Center at Salem Regional Medical Center Salem OH
University of Hawaii Cancer Center Honolulu HI
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Missouri - Ellis Fischel Columbia MO
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Pennsylvania Medical Center Philadelphia PA
University of Pennsylvania/Abramson Cancer Center Philadelphia PA
University of South Alabama Mobile AL
University of Texas Medical Branch Galveston TX
UPMC-Mercy Hospital Pittsburgh PA
Upstate Carolina CCOP Spartanburg SC
Utah Valley Regional Medical Center Provo UT
Valley Hospital Paramus NJ
Veterans Administration Long Beach Medical Center Long Beach CA
Virginia Mason CCOP Seattle WA
Virginia Mason Medical Center Seattle WA
Virtua Memorial Mount Holly NJ
Warren Radiation Therapy Center Warren NJ
Washington Cancer Institute Washington DC
Washington University School of Medicine St. Louis MO
WellSpan Health-York Hospital York PA
West Florida Cancer Institute Pensacola FL
West Penn Hospital Pittsburgh PA
Wheaton Franciscan Cancer Care-All Saints Racine WI
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
Wyoming Valley Health Care System - Hospital Wilkes-Barre PA
Updated: 4/13/2011

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