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RTOG 0120 Protocol Information

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A Randomized Phase I/II Study of Preoperative Radiotherapy With/Without Sugen 5416 (NSC #696819; A TK Inhibitor Anti-Angiogenesis Compound) in the Management of Low to Intermediate Grade Soft Tissue Sarcoma of the Trunk or Extremity
Protocol Documents
Current Version Date: 8/1/2001
Principal Investigator: Burton L. Eisenberg, M.D.
Primary Objective:

To assess the dose escalation toxicity of SU5416 and radiation therapy in a clinical design for the purpose of determining the maximum tolerated dose (MTD) of SU5416 in a combined modality setting. 

To assess whether SU5416 has quantitative anti-angiogenic effects in vivo. 
Patient Population:

 

  • Histologically confirmed, locally confined, soft tissue sarcoma, low or intermediate grade (G1/2) and measures > 5cm; located on upper or lower extremities or body wall.
  • AJCC (1998) G1 or G2 (on a 1-4 scale), T2a or T2b (Stage IB, IIA).
  • Treatment must begin within two weeks after registration.
  • No evidence of metastases.
  • No prior chemotherapy, irradiation or biotherapy for this tumor.
  • Zubrod 0-1.
  • WBC >/= 4000/mm3 or ANC = 1800/mm3; platelets >/= 100,000/mm3; total bilirubin </=1.5 mg/dl, creatinine </= 1.5 mg/dl or creatinine clearance >50 ml/min, SGOT </= 50; PT, PTT < 1.25 x normal (prior to coumadin), fibrin split products < 2 x normal, fibrinogen > 200 mg/dl.
  • No minor surgery (e.g. port placement) less than two weeks prior to study entry; no major surgery less than four weeks prior to study entry.
  • No pregnant or lactating women.
  • Signed study-specific consent prior to study entry.
Target Accrual: 46
Current Accrual: 1
Status: Terminated
Date: 10/18/2002
Participating Sites:
Akron General Medical Center Akron OH
Alta Bates Hospital Comprehensive Cancer Center Berkeley CA
Baptist Hospital of Miami Miami FL
Bay Area Tumor Institute Oakland CA
California Pacific Medical Center-Pacific Campus San Francisco CA
Cottonwood Hospital Medical Center Murray UT
Cross Cancer Institute Edmonton, Alberta
Dixie Medical Center Regional Cancer Center East St. George UT
Finley Hospital Dubuque IA
Fox Chase Cancer Center Philadelphia PA
Gundersen Lutheran Medical Center La Crosse WI
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Mills-Peninsula Medical Center San Mateo CA
Moffitt Cancer Center Tampa FL
Northwestern University Chicago IL
Roswell Park Cancer Institute Buffalo NY
Southeast Cancer Control Consortium CCOP Winston Salem NC
Sutter Health Western Division Cancer Research Group Novato CA
Tulane University Medical Center New Orleans LA
Union Hospital Terre Haute IN
University of California Davis Comprehensive Cancer Center Sacramento CA
Upstate Carolina CCOP Spartanburg SC
Updated: 4/8/2011

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