A Phase II Study to Evaluate Transoral CO2 Laser Supraglottic Laryngectomy and Irradiation in Stage I, II and III Squamous Cell Carcinoma of the Supraglottic Larynx
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Phase II Study to Evaluate Transoral CO2 Laser Supraglottic Laryngectomy and Irradiation in Stage I, II and III Squamous Cell Carcinoma of the Supraglottic Larynx
OBJECTIVES: I. Assess the feasibility of treating untreated stage I, II and selected stage
III squamous cell carcinoma of the supraglottic larynx with endoscopic surgery and
irradiation. II. Estimate the 3 year progression free survival and describe the location of
disease progression.
OUTLINE: Patients receive carbon dioxide laser laryngectomy within 28 days following
protocol registration. Patients with N1 disease may undergo an optional neck dissection
ipsilateral to the neck mass. Neck dissection includes complete removal of at least lymph
node levels 2-4. Radiation therapy begins 14 days following laser surgery. Patients are
followed every 3 months for the first year, every 6 months for the second year, and every 12
months thereafter until death.
PROJECTED ACCRUAL: There will be 50 patients accrued into this study in 3 years with an
estimated accrual rate of 20 patients per year.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven, newly diagnosed, untreated stage I, II, or
selected stage III (T1-T2, N1, M0) squamous cell carcinoma of the supraglottic larynx
Bidimensionally measurable disease No metastatic or stage III T3 disease No immediate
life-threatening complications of the disease
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0 or 1 Life expectancy: Not
specified Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 50,000/mm3
Hemoglobin greater than 10.0 g/dL Hepatic: Not specified Renal: Not specified
Cardiovascular: At least 3 months since prior myocardial infarction No uncontrolled
congestive heart failure No unstable or uncontrolled angina Other: No prior malignancy
except for the following: Adequately treated basal cell or squamous cell skin cancer In
situ cervical cancer Other cancer for which the patient has been disease-free for at least
five years No history of prior laryngeal cancer No history of primary tumors of any
aerodigestive tract site except disease site All fertile patients must use an effective
contraceptive method Must be medically able to undergo general anesthesia No
psychological, familial, sociological or geographical conditions that do not permit
medical follow-up and compliance with study protocol No other unstable or pre-existing
major medical condition
PRIOR CONCURRENT THERAPY: No prior treatment for squamous cell carcinoma of the
supraglottic larynx
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
feasibility
Outcome Description:
To test the ability to accrue patients to the study at a rate compatible with efficiency (20 patients per year).
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Roy K. Davis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Utah
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000065668
NCT ID:
NCT00003040
Start Date:
September 1997
Completion Date:
December 2007
Related Keywords:
- Head and Neck Cancer
- stage I squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the larynx
- Laryngeal Neoplasms
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| University of California Davis Medical Center | Sacramento, California 95817 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Oregon Cancer Center | Portland, Oregon 97201-3098 |
