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

Phase 2

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Procedure: laser surgery; Radiation: radiation therapy

• Registration Number: NCT00003040
• Lead Sponsor: SWOG Cancer Research Network

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.

Study Timeline

• Study Start: 1997-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-02-27
• Study First Posted: 2004-03-01
• Primary Completion: 2007-02
• Study Completion: 2007-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transoral CO2 laser laryngectomy and RT	laser surgery	Transoral CO2 laser supraglottic laryngectomy and irradiation
Transoral CO2 laser laryngectomy and RT	radiation therapy	Transoral CO2 laser supraglottic laryngectomy and irradiation

Primary Outcome Measures

Name	Time	Method
feasibility	4 years	To test the ability to accrue patients to the study at a rate compatible with efficiency (20 patients per year).

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Arthur G. James Cancer Hospital - Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States

St. Louis University Health Sciences Center; 🇺🇸 Saint Louis, Missouri, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Oregon Cancer Center; 🇺🇸 Portland, Oregon, United States

Albert B. Chandler Medical Center, University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of Colorado Cancer Center; 🇺🇸 Denver, Colorado, United States

USC/Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States