NCT00003040

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

March 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

9.4 years

First QC Date

November 1, 1999

Last Update Submit

June 13, 2012

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • feasibility

    To test the ability to accrue patients to the study at a rate compatible with efficiency (20 patients per year).

    4 years

Secondary Outcomes (2)

  • progression-free survival

    3 years

  • return to swallowing function

    two weeks

Study Arms (1)

Transoral CO2 laser laryngectomy and RT

EXPERIMENTAL

Transoral CO2 laser supraglottic laryngectomy and irradiation

Procedure: laser surgeryRadiation: radiation therapy

Interventions

laser surgeryPROCEDURE

CO2 supraglottic laryngectomy within 28 days following registration with neck dissection as needed

Also known as: CO2 laser surgery
Transoral CO2 laser laryngectomy and RT
radiation therapyRADIATION

200 cGy per day, five days per week for approximately 6 weeks, to begin 14 days after laser surgery

Also known as: RT
Transoral CO2 laser laryngectomy and RT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Oregon Cancer Center

Portland, Oregon, 97201-3098, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related 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 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.

    PMID: 17938330RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Laser TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Roy K. Davis, MD

    University of Utah

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 1, 2004

Study Start

September 1, 1997

Primary Completion

February 1, 2007

Study Completion

December 1, 2007

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

US(12)