Endoscopic Surgery or Radiation Therapy in Treating Patients With Stage 0, Stage I, or Stage II Laryngeal Cancer of the Glottis
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00334997
- Lead Sponsor
- University College London Hospitals
- Brief Summary
RATIONALE: Endoscopic surgery is a less invasive type of surgery for laryngeal cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether endoscopic surgery is more effective than radiation therapy in treating laryngeal cancer of the glottis.
PURPOSE: This randomized phase II trial is studying endoscopic surgery to see how well it works compared with radiation therapy in treating patients with stage 0, stage I, or stage II laryngeal cancer of the glottis.
- Detailed Description
OBJECTIVES:
* Determine the feasibility of conducting a large phase III randomized study in the future, comparing radiotherapy vs endoscopic excision in patients with stage 0-II laryngeal cancer of the glottis.
* Determine patient acceptability of the proposed trial design.
* Compare the effect of using dedicated head and neck research nurses vs general nurses on patient recruitment.
* Refine outcome measures, including voice analysis and quality of life.
OUTLINE: This is a randomized, controlled, multicenter, pilot study. Patients are stratified according to participating center and T stage (Tis or T1 vs T2a). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo endoscopic excision via CO_2 laser or cold steel.
* Arm II: Patients undergo radiotherapy once daily, 5 days a week, for 3-4 weeks. Patients undergo vocal analysis at baseline and at 6 months and 1 and 2 years after randomization.
Quality of life is assessed at baseline, at 1 year, and then annually for 5 years.
After completion of study treatment, patients are followed periodically for up to 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility Patient acceptability
- Secondary Outcome Measures
Name Time Method Voice analysis Quality of life Economic assessment
Trial Locations
- Locations (6)
Southmead Hospital
🇬🇧Bristol, England, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Royal Infirmary - Castle
🇬🇧Glasgow, Scotland, United Kingdom
Southmead Hospital🇬🇧Bristol, England, United Kingdom