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

Head and Neck Cancer Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00003040
Study type Interventional
Source Southwest Oncology Group
Contact
Status Terminated
Phase Phase 2
Start date September 1997
Completion date December 2007
View Details
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