Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]
- 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
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.
Allocation: Randomized, Primary Purpose: Treatment
Martin A. Birchall, MD
United States: Federal Government