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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck


OBJECTIVES: I. Determine the percentage of patients for whom a complete course of therapy
can be administered using targeted supradose cisplatin chemoradiation in patients with
squamous cell carcinoma of the head and neck. II. Determine the partial and complete
response rate of cisplatin chemoradiation. III. Determine the incidence of adverse events
using cisplatin chemoradiation therapy. IV. Determine the rate of disease-free survival and
overall survival in these patients. V. Determine the incidence and pattern of recurrence in
these patients. VI. Document quality of life measured by disease-specific instruments in
these patients.

OUTLINE: All patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent
with radiotherapy. One course of chemotherapy consists of intra-arterial cisplatin given
over 3-5 minutes. Radiotherapy is given 5 days a week for 7 weeks. This weekly cisplatin
chemoradiation course will be repeated 4 times, providing recovery from toxicity is present.
Dexamethasone is started the evening prior to cisplatin treatment, and continues until the
morning following the procedure.

PROJECTED ACCRUAL: 60 patients will be enrolled.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the oral cavity,
oropharynx, hypopharynx, or larynx No distant metastatic disease No previous or concurrent
head and neck primaries No lip, nasopharynx, or salivary gland lesions No recurrent tumors
Stage IV disease comprised of T4 NO-3 lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky greater than 60
Life Expectancy: Not specified Hematopoietic: ANC greater than 2,000 Platelet count
greater than 100,000 Hepatic: Not specified Renal: Creatinine clearance greater than 50
mL/min Cardiovascular: Not specified Other: Not pregnant or nursing No adverse medical
illnesses No imaging studies performed greater than one month preregistration No
laboratory studies greater than 2 weeks preregistration No other malignancies, except for
basal or squamous cell of the skin, within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the
head and neck Surgery: No prior surgery to study site other than a biopsy Other: Protocol
treatment must begin within 8 weeks of biopsy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

K. Thomas Robbins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Florida

Authority:

United States: Federal Government

Study ID:

CDR0000065366

NCT ID:

NCT00002932

Start Date:

May 1997

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Green Mountain Oncology GroupRutland, Vermont  05701
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Fletcher-Allen Health CareBurlington, Vermont  05401
University Cancer CenterSeattle, Washington  98195
University of Washington Neutron Facility and Cancer CenterSeattle, Washington  98195