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RTOG 9615 Protocol Information

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Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck
Protocol Documents
Current Version Date: 9/3/1999
Principal Investigator: K. Thomas Robbins, M.D.
Primary Objective:

To determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose DDP chemoradiation (RADPLAT program) in a multi- institutional setting for the purpose of expanding the availability of the protocol to patients with advanced head and neck cancer.

Patient Population:
  • Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • Stage IV disease comprised of only T4 N0-3 M0 lesions
  • Karnofsky >/= 60
  • Age >/= 18
  • No distant metastases
  • No prior chemotherapy or radiation therapy to the head or neck
  • ANC >/= 2000, platelets >/= 100,000, and calculated or 24 hour creatinine clearance > 50
  • Protocol treatment must begin </= 8 weeks after biopsy
  • No prior (£ 5 years) or concurrent malignancies
  • No pregnant or lactating women
  • Study-specific consent form
Target Accrual: 60
Current Accrual: 67
Status: Terminated
Date: 3/3/2005
Participating Sites:
Advocate Lutheran General Hospital Park Ridge IL
Baptist Cancer Institute CCOP Memphis TN
Radiation Therapy Oncology Group Philadelphia PA
Saint Peter's University Hospital New Brunswick NJ
UCSF Medical Center-Mount Zion San Francisco CA
University of Iowa/Holden Comprehensive Cancer Center Iowa City IA
University of Tennessee Health Science Center Memphis TN
University of Vermont Medical Center Burlington VT
University of Virginia Cancer Center Charlottesville VA
Vanderbilt University/Ingram Cancer Center Nashville TN
Wyoming Valley Health Care System - Hospital Wilkes-Barre PA
Updated: 4/8/2011

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