Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with stage II cancer of the vocal cord. PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating patients who have stage II cancer of the vocal cord.

Detailed Description
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OBJECTIVES: Compare the local response rate in patients with stage II invasive squamous cell carcinoma of the true vocal cord treated with hyperfractionation vs conventional fractionation radiotherapy. Compare the acute and late toxic effects of these regimens in this patient population. Compare the overall and disease-free survival patterns in this patient population treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to substage (T2a vs T2b). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2 weeks. Arm II: Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1.6 weeks. Patients with biopsy-proven persistent disease at least 6 weeks after completion of radiotherapy undergo salvage surgery with neck dissection (at the discretion of the surgeon). Patients are followed at 4 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 3.2 years.

Official Title
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A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven invasive squamous cell carcinoma of the true vocal cord Stage II (T2a/b N0) disease with bulk of tumor present on vocal cord (i.e., the epicenter) with extension to adjacent areas No verrucal carcinoma or adenocarcinoma No extension to pre-epiglottic space or pyriform sinus No fixed cord or cartilage invasion No evidence of adenopathy, including any of the following: Nodes larger than 1 cm by radiography Nodes containing a low central density consistent with necrosis by radiography Clinically palpable nodes larger than 1 cm and firm in consistency No recurrent or persistent disease No evidence or suspicion of distant metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 5 years except nonmelanomatous skin cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the mid-neck or larynx Surgery: No prior complete stripping or laser excision of all gross disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiation therapy - conventional fractionation<br>Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions | Radiation: radiation therapy<br> <br> |
| Experimental: Radiation therapy - hyperfractionation<br>Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions | Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control |  | From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Toxicity |  | From start of treatment to 90 days | 
| Late Toxicity |  | From 91 days after start of treatment to last follow-up. | 
| Overall Survival |  | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years | 
| Disease-free Survival |  | From randomization to date of failure (local, regional, or distant progression, second primary tumor, or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. | 

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