Head and Neck Cancer Clinical Trial
Official title:
Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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