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 Details — Status: Terminated

Administrative data

• NCT number: NCT00003040
• Other study ID #: CDR0000065668
• Secondary ID: U10CA032102S9709
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 13, 2012
• Start date: September 1997
• Est. completion date: December 2007

Study information

• Verified date: June 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: December 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• laser surgery
CO2 supraglottic laryngectomy within 28 days following registration with neck dissection as needed

Radiation:
• radiation therapy
200 cGy per day, five days per week for approximately 6 weeks, to begin 14 days after laser surgery

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	University of Colorado Cancer Center	Denver	Colorado
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Oregon Cancer Center	Portland	Oregon
United States	University of California Davis Medical Center	Sacramento	California
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility	To test the ability to accrue patients to the study at a rate compatible with efficiency (20 patients per year).	4 years	No
Secondary	progression-free survival	From date of registration to date of first observation of progressive disease, death due to any cause or early discontinuation of treatment	3 years	No
Secondary	return to swallowing function	how long patients require feeding tubes and the proportion of patients requiring tracheostomy	two weeks	Yes