NCT00334997

Endoscopic Surgery or Radiation Therapy in Treating Patients With Stage 0, Stage I, or Stage II Laryngeal Cancer of the Glottis

Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University College London Hospitals · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
PROCEDURE	endoscopic surgery
PROCEDURE	laser surgery
RADIATION	radiation therapy

Timeline

• Start date: 2005-09-01
• Completion: 2006-07-01
• First posted: 2006-06-08
• Last updated: 2013-12-19

Locations

6 sites across 1 country: United Kingdom