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RTOG 0017 Protocol Information

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A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy for Patients with Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Protocol Documents
Current Version Date: 4/27/2004
Principal Investigator: Hak Choy, M.D.
Primary Objective:

To determine the maximal tolerated dose (MTD) of gemcitabine when administered with carboplatin and thoracic radiation therapy followed by adjuvant chemotherapy for patients with NSCLC.

Patient Population:

Medically inoperable stage IIIA or unresectable stages IIIA & IIIB non-small cell lung cancer

Measurable disease on the planning CT

Zubrod Status 0 and 1

Weight loss </=10% in 3 months prior to diagnosis

FEV 1> 1000 cc

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 pleural effusion on CXR, unless after thoracotomy or invasive thoracic procedure

No distant metastasis, prior chemo- or thoracic or neck radiation therapy

No recurrent disease or prior complete tumor resection

No prior invasive malignancy unless >/=3 years and currently disease-free

Signed study-specific consent form prior to registration
Target Accrual: 78
Current Accrual: 35
Status: Terminated
Date: 6/30/2010
Participating Sites:
Abbott-Northwestern Hospital Minneapolis MN
Arizona Oncology Services Foundation Scottsdale AZ
Bay Area Tumor Institute Oakland CA
Bay Medical Center Panama City FL
California Cancer Center - Fresno Fresno CA
Cancer Treatment Center Wooster OH
Central Illinois CCOP Decatur IL
Christiana Care Health System-Christiana Hospital Newark DE
Cleveland Clinic Akron General Akron OH
Columbia Saint Mary's Water Tower Medical Commons Milwaukee WI
Cottonwood Hospital Medical Center Murray UT
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Center Regional Cancer Center East St. George UT
East Bay Radiation Oncology Center Castro Valley CA
Einstein Medical Center Philadelphia Philadelphia PA
Fairview Ridges Hospital Burnsville MN
Fairview-Southdale Hospital Edina MN
Finley Hospital Dubuque IA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Gulf Coast Cancer Treatment Center Panama City FL
Gundersen Lutheran Medical Center La Crosse WI
Highland Hospital Rochester NY
Huntsman Cancer Institute/University of Utah Salt Lake City UT
Intermountain Medical Center Murray UT
IU Health Ball Memorial Hospital Muncie IN
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore MD
Kansas City CCOP Prairie Village KS
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Liberty Hospital Liberty MO
McKay-Dee Hospital Center Ogden UT
Mercy Catholic Medical Center - Fitzgerald Darby PA
Mercy Hospital Coon Rapids MN
Metro-Minnesota CCOP St. Louis Park MN
Monmouth Medical Center Long Branch NJ
Mount Sinai Union Square New York NY
Mount Sinai West New York NY
North Memorial Medical Health Center Robbinsdale MN
Novant Health Forsyth Medical Center Winston Salem NC
Orange Regional Medical Center Middletown NY
Pocono Medical Center East Strousburg PA
Radiation Oncology Center Alliance OH
Regional Hospital of Scranton Scranton PA
Ridgeview Medical Center Waconia MN
Sandra L Maxwell Cancer Center Cedar City UT
Sands Cancer Center Canandaigua NY
Sequoia Regional Cancer Center Visalia CA
Southeast Cancer Control Consortium CCOP Winston Salem NC
St. Anthony Cancer Care Institute at St. Anthony Hospital Oklahoma City OK
State University of New York Downstate Medical Center Brooklyn NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
The Cancer Center for Southern Kentucky Bowling Green KY
Thomas Jefferson University Hospital Philadelphia PA
Toledo Community Hospital Oncology Program CCOP Toledo OH
UH Seidman Cancer Center at Salem Regional Medical Center Salem OH
United Hospital St. Paul MN
Unity Hospital Fridley MN
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Rochester Rochester NY
University of Texas Medical Branch Galveston TX
University of Texas Southwestern Medical School Dallas TX
UPMC-Mercy Hospital Pittsburgh PA
UT Southwestern/Simmons Cancer Center-Dallas Dallas TX
Utah Cancer Specialists-Salt Lake City Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Vanderbilt University/Ingram Cancer Center Nashville TN
Virtua Memorial Mount Holly NJ
Wayne Memorial Hospital Goldsboro NC
Wayne Radiation Oncology Goldsboro NC
West Penn Hospital Pittsburgh PA
Zablocki VA Medical Center-Wood Milwaukee WI
Updated: 4/7/2011

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