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RTOG 0124 Protocol Information

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A Phase II Study of Multimodality Therapy for Primary and Recurrent Retroperitoneal Sarcomas
Protocol Documents
Current Version Date: 12/3/2002
Principal Investigator: Peter W. T. Pisters, M.D.
Primary Objective:

To assess overall survival of retroperitoneal sarcomas after integrated chemotherapy, radiation, and surgery.

Patient Population:

 

  • Histologically confirmed, non-metastatic, soft tissue sarcoma of the retroperitoneum and/or pelvis with measurable disease which has not been debulked
  • High-grade disease (grade 3/3, 3/4, 4/4 primary or recurrent) > 5 cm or recurrent, moderate grade (grade 2/3, 2/4) disease > 10 cm by CT scan (see Appendix III)
  • No evidence of metastases; no multifocal disease suggestive of regional nodal involvement
  • Gross total resection (R0 or R1) must be feasible
  • Zubrod 0-2
  • > 65 years of age patients may be enrolled after evaluation by medical oncologist; two functional kidneys
  • Normal cardiac function (Ejection fraction >/= 50% within the past six months)
  • ANC >/= 1,500/mm3; platelets >/= 100,000/mm3; bilirubin </= 1.5 mg/dl, AST </=3 x the upper limits of normal (ULN); creatinine </= 1.6 mg/dl; albumin>/=3.5 g/dl
  • Oral caloric intake >/= 1500 kCal/d; no hypersensitivity to E. coli derived products
  • No prior radiation therapy to the abdomen or pelvis
  • No prior chemotherapy for sarcoma or prior doxorubicin/ifosfamide
  • Signed study-specific consent prior to study entry

 

Target Accrual: 48
Current Accrual: 5
Status: Terminated
Date: 3/25/2004
Participating Sites:
Bay Area Tumor Institute Oakland CA
Case Western Reserve University Cleveland OH
Cleveland Clinic Akron General Akron OH
Cross Cancer Institute Edmonton, Alberta
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center Lebanon NH
Dayton CCOP Kettering OH
Dixie Medical Center Regional Cancer Center East St. George UT
Finley Hospital Dubuque IA
Fox Chase Cancer Center Philadelphia PA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Gundersen Lutheran Medical Center La Crosse WI
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis IN
Kansas City CCOP Prairie Village KS
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Liberty Hospital Liberty MO
M D Anderson Cancer Center Houston TX
Mayo Clinic Rochester MN
McGill University Department of Oncology Montreal
McKay-Dee Hospital Center Ogden UT
Mobile Infirmary Medical Center Mobile AL
Moffitt Cancer Center Tampa FL
Northwestern University Chicago IL
Novant Health Forsyth Medical Center Winston Salem NC
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Richard L. Roudebush VA Medical Center Indianapolis IN
Roswell Park Cancer Institute Buffalo NY
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Southeast Cancer Control Consortium CCOP Winston Salem NC
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Tulane University Health Sciences Center New Orleans LA
Union Hospital Terre Haute IN
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Missouri - Ellis Fischel Columbia MO
Utah Valley Regional Medical Center Provo UT
Virtua Memorial Mount Holly NJ
Washington University School of Medicine St. Louis MO
West Penn Hospital Pittsburgh PA
Updated: 4/8/2011

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