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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of California Davis Medical CenterSacramento, California  95817
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Huntsman Cancer InstituteSalt Lake City, Utah  84112
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Oregon Cancer CenterPortland, Oregon  97201-3098