S9709, Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Procedure: laser surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transoral CO2 laser laryngectomy and RT<br>Transoral CO2 laser supraglottic laryngectomy and irradiation | Procedure: laser surgery<br>* CO2 supraglottic laryngectomy within 28 days following registration with neck dissection as needed<br>* Other names: CO2 laser surgery;Radiation: radiation therapy<br>* 200 cGy per day, five days per week for approximately 6 weeks, to begin 14 days after laser surgery<br>* Other names: RT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility | To test the ability to accrue patients to the study at a rate compatible with efficiency (20 patients per year). | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | From date of registration to date of first observation of progressive disease, death due to any cause or early discontinuation of treatment | 3 years | 
| return to swallowing function | how long patients require feeding tubes and the proportion of patients requiring tracheostomy | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx