RATIONALE: Laser surgery for cancer of the larynx may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy and laser surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of laser surgery plus radiation therapy in treating patients with early stage cancer of the larynx.

Condition	Treatment or Intervention	Phase
stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the larynx	Procedure: Carbon dioxide laser therapy  Procedure: Radiation therapy	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• No prior treatment for squamous cell carcinoma of the supraglottic larynx

--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

Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States
California
      University of California Davis Medical Center, Sacramento,  California,  95817,  United States
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
Oregon
      Oregon Cancer Center, Portland,  Oregon,  97201-3098,  United States
Texas
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States
Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States

Study chairs or principal investigators

Roy Kim Davis,  Study Chair,  Southwest Oncology Group   

Study ID Numbers:  CDR0000065668; SWOG-S9709
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003040
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08