Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck
18 Years
N/A
Both
Head and Neck Cancer
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 Clinics | Iowa City, Iowa 52242 |
| MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
| CCOP - Baptist Cancer Institute | Memphis, Tennessee 38117 |
| University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
| University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
| Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
| Green Mountain Oncology Group | Rutland, Vermont 05701 |
| Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
| Fletcher-Allen Health Care | Burlington, Vermont 05401 |
| University Cancer Center | Seattle, Washington 98195 |
| University of Washington Neutron Facility and Cancer Center | Seattle, Washington 98195 |
