Spots Global Cancer Trial Database for S9709, Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx
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Trial Identification
Brief Title: S9709, Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx
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
Study ID: NCT00003040
Conditions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
University of California Davis Medical Center, Sacramento, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Oregon Cancer Center, Portland, Oregon, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Contact Details
Name: Roy K. Davis, MD
Affiliation: University of Utah
Role: STUDY_CHAIR
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