Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Feasibility
Patient acceptability
次要结局
- Quality of life
- Economic assessment
- Voice analysis