Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI	SWOG-S9709 NCT00003040, S9709

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.

Entry 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

Prior/Concurrent Therapy:

No prior treatment for squamous cell carcinoma of the supraglottic larynx

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

Expected Enrollment

There will be 50 patients accrued into this study in 3 years with an estimated 
accrual rate of 20 patients per year.

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.

Agrawal A, Moon J, Davis RK, et al.: 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 133 (10): 1044-50, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Roy Davis, MD, Protocol chair(Contact information may not be current)		Ph: 801-585-0303; 877-585-0303

Registry Information
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
Trial Start Date		1997-09-15
Registered in ClinicalTrials.gov		NCT00003040
Date Submitted to PDQ		1997-08-18
Information Last Verified		2007-10-29
NCI Grant/Contract Number		CA32102

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