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

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
laser surgery
radiation therapy
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • USC/Norris Comprehensive Cancer Center and Hospital
  • University of California Davis Medical Center
  • University of Colorado Cancer Center
  • Albert B. Chandler Medical Center, University of Kentucky
  • University of Mississippi Medical Center
  • St. Louis University Health Sciences Center
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital - Ohio State University
  • Oregon Cancer Center
  • University of Texas Health Science Center at San Antonio
  • Huntsman Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transoral CO2 laser laryngectomy and RT

Arm Description

Transoral CO2 laser supraglottic laryngectomy and irradiation

Outcomes

Primary Outcome Measures

feasibility
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
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
how long patients require feeding tubes and the proportion of patients requiring tracheostomy

Full Information

First Posted
November 1, 1999
Last Updated
June 13, 2012
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003040
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
September 1997 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transoral CO2 laser laryngectomy and RT
Arm Type
Experimental
Arm Description
Transoral CO2 laser supraglottic laryngectomy and irradiation
Intervention Type
Procedure
Intervention Name(s)
laser surgery
Other Intervention Name(s)
CO2 laser surgery
Intervention Description
CO2 supraglottic laryngectomy within 28 days following registration with neck dissection as needed
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
RT
Intervention Description
200 cGy per day, five days per week for approximately 6 weeks, to begin 14 days after laser surgery
Primary Outcome Measure Information:
Title
feasibility
Description
To test the ability to accrue patients to the study at a rate compatible with efficiency (20 patients per year).
Time Frame
4 years
Secondary Outcome Measure Information:
Title
progression-free survival
Description
From date of registration to date of first observation of progressive disease, death due to any cause or early discontinuation of treatment
Time Frame
3 years
Title
return to swallowing function
Description
how long patients require feeding tubes and the proportion of patients requiring tracheostomy
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy K. Davis, MD
Organizational Affiliation
University of Utah
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Oregon Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17938330
Citation
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. doi: 10.1001/archotol.133.10.1044.
Results Reference
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S9709, Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx

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