Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 12
- Primary Endpoint
- Feasibility
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma of the glottic larynx, including tumors at the anterior commissure
- •Stage 0-II (Tis, T1, or T2a)
- •No clinical or radiological sign of nodal involvement
- •No evidence of distant metastases
- •Airway anatomy suitable for endoscopic excision
- •PATIENT CHARACTERISTICS:
- •Fit to receive radical treatment as either radiotherapy or endoscopic excision
- •Life expectancy ≥ 2 years
- •No other cancer in the past 10 years except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the uterine cervix
- •No vasculitic conditions adversely affecting radiotherapy
- •No other co-existing medical condition that would limit life expectancy
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •No concurrent chemotherapy
- •No concurrent palliative treatment
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility
Patient acceptability
Secondary Outcomes
- Quality of life
- Economic assessment
- Voice analysis