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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Procedure: endoscopic surgery
* Procedure: laser surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: endoscopic surgery|nan|
|Procedure: laser surgery|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility |  |  | 
| Patient acceptability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice analysis |  |  | 
| Quality of life |  |  | 
| Economic assessment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage 0 laryngeal cancer