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RTOG 9904 Protocol Information

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A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy For Potentially Resectable Adenocarcinoma of the Stomach
Protocol Documents
Current Version Date: 3/4/2004
Principal Investigator: Jaffer A. Ajani, M.D.
Primary Objective:

To determine the feasibility of preoperative chemoradiotherapy for patients with potentially resectable adenocarcinoma of the stomach

Patient Population:
  • Patients with potentially resectable adenocarcinoma of the stomach with histologic proof.
  • EUS stage T2-3, any N, M0.
  • Adequate bone marrow (defined as peripheral absolute granulocyte count of > 2,000/μL, and platelet count of >100,000/μL), liver (bilirubin ≤1.5 mg/dl), and renal functions (creatinine < 1.5 mg/dl).
  • Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
  • No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
  • Patients must have a life expectancy of at least 16 weeks.
  • Performance status of ≤ 2 (Zubrod scale).
  • No biopsy proof of lymph node metastases outside the study field.
  • No evidence of metastatic disease to distant organs.
  • No presence of concurrent or previous malignancies ≤ 5 years, other than noninvasive skin cancer.
  • No uncontrolled or severe cardiac disease, diabetes or hypertension.
  • Signed study-specific consent form prior to study entry.

 

Target Accrual: 49
Current Accrual: 49
Status: Terminated
Date: 6/30/2010
Participating Sites:
21st Century Oncology Ft. Myers FL
Advocate Good Samaritan Hospital Downers Grove IL
Advocate Good Shepherd Hospital Barrington IL
Advocate Illinois Masonic Medical Center Chicago IL
Advocate Lutheran General Hospital Park Ridge IL
Alta Bates Summit Medical Center-Herrick Campus Berkeley CA
Atlanta Regional CCOP Atlanta GA
Baptist Hospital St Pensacola FL
Bay Area Tumor Institute Oakland CA
Bay Medical Center Panama City FL
Bon Secours Saint Mary's Hospital Richmond VA
California Pacific Medical Center-Pacific Campus San Francisco CA
Case Western Reserve University Cleveland OH
Colorado Cancer Research Program CCOP Denver CO
Columbia Saint Mary's Water Tower Medical Commons Milwaukee WI
Cottonwood Hospital Medical Center Murray UT
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center Lebanon NH
Dayton CCOP Kettering OH
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Center Regional Cancer Center East St. George UT
East Carolina University Greenville NC
East Bay Radiation Oncology Center Castro Valley CA
Einstein Medical Center Philadelphia Philadelphia PA
Finley Hospital Dubuque IA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Froedtert Memorial Lutheran Hospital Milwaukee WI
Greenville Health System Cancer Institute-Eastside Greenville SC
Gundersen Lutheran Medical Center La Crosse WI
Halifax Health Medical Center-Centers for Oncology Daytona Beach FL
Harbor Hospital Center Baltimore MD
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse NY
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis IN
IU Health Ball Memorial Hospital Muncie IN
John Muir Medical Center-Concord Concord CA
Kansas City CCOP Prairie Village KS
Lankenau Medical Center Wynnewood PA
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Liberty Hospital Liberty MO
M D Anderson Cancer Center Houston TX
Mainline Health CCOP Wynnewood PA
McKay-Dee Hospital Center Ogden UT
McLaren Cancer Institute-Flint Flint MI
Mercy Hospital Springfield Springfield MO
Miami Cancer Institute Miami FL
Mills-Peninsula Medical Center San Mateo CA
Mobile Infirmary Medical Center Mobile AL
Monmouth Medical Center Long Branch NJ
Nebraska Methodist Hospital Omaha NE
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn NY
Northridge Hospital Medical Center Northridge CA
Northwest Community Hospital Arlington Heights IL
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Piedmont Hospital Atlanta GA
Porter Adventist Hospital Denver CO
Providence Alaska Medical Center Anchorage AK
Rapid City Regional Hospital Rapid City SD
Regional Hospital of Scranton Scranton PA
Richard L. Roudebush VA Medical Center Indianapolis IN
Roswell Park Cancer Institute Buffalo NY
Saint Joseph Regional Medical Center-Mishawaka Mishawaka IN
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
SCL Health Saint Joseph Hospital Denver CO
Southeast Cancer Control Consortium CCOP Winston Salem NC
Southwestern Vermont Medical Center Bennington VT
State University of New York Downstate Medical Center Brooklyn NY
Sutter Cancer Research Consortium Novato CA
The Cancer Center for Southern Kentucky Bowling Green KY
The Don and Sybil Harrington Cancer Center Amarillo TX
Thomas Jefferson University Hospital Philadelphia PA
Trinity Cancer Care Center Minot ND
UCLA / Jonsson Comprehensive Cancer Center Los Angeles CA
Union Hospital Terre Haute IN
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Cincinnati/Barrett Cancer Center Cincinnati OH
University of Colorado Hospital Aurora CO
University of Missouri - Ellis Fischel Columbia MO
University of South Alabama Mobile AL
University of Texas Medical Branch Galveston TX
Upstate Carolina CCOP Spartanburg SC
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Virtua Memorial Mount Holly NJ
Washington University School of Medicine St. Louis MO
West Penn Hospital Pittsburgh PA
Western Oncology Research Consortium Portland OR
Yale-New Haven Hospital Saint Raphael Campus New Haven CT
Zablocki VA Medical Center-Wood Milwaukee WI
Updated: 4/13/2011

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