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

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Procedure: laser surgery Radiation: radiation therapy	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

feasibility [ Time Frame: 4 years ] [ Designated as safety issue: No ]
To test the ability to accrue patients to the study at a rate compatible with efficiency (20 patients per year).

Secondary Outcome Measures:

progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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 [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
how long patients require feeding tubes and the proportion of patients requiring tracheostomy

Enrollment:	42
Study Start Date:	September 1997
Study Completion Date:	December 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Transoral CO2 laser laryngectomy and RT Transoral CO2 laser supraglottic laryngectomy and irradiation	Procedure: laser surgery CO2 supraglottic laryngectomy within 28 days following registration with neck dissection as needed Other Name: CO2 laser surgery Radiation: radiation therapy 200 cGy per day, five days per week for approximately 6 weeks, to begin 14 days after laser surgery Other Name: RT

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003040

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Oregon
Oregon Cancer Center
Portland, Oregon, United States, 97201-3098
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Roy K. Davis, MD

University of Utah

More Information

Publications:

Agrawal A, Moon J, Davis RK, Sakr WA, Giri SP, Valentino J, LeBlanc M, Truelson JM, Yoo GH, Ensley JF, Schuller DE; Southwest Oncology Group. Transoral carbon dioxide laser supraglottic laryngectomy and irradiation in stage I, II, and III squamous cell carcinoma of the supraglottic larynx: report of Southwest Oncology Group Phase 2 Trial S9709. Arch Otolaryngol Head Neck Surg. 2007 Oct;133(10):1044-50.

Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00003040 History of Changes
Other Study ID Numbers:	CDR0000065668, U10CA032102, S9709
Study First Received:	November 1, 1999
Last Updated:	June 13, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:

stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx

Additional relevant MeSH terms:

Laryngeal Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases

Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on May 23, 2013