Endoscopic Surgery or Radiation Therapy in Treating Patients With Stage 0, Stage I, or Stage II Laryngeal Cancer of the Glottis
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|ClinicalTrials.gov Identifier: NCT00334997|
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Procedure: endoscopic surgery Procedure: laser surgery Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]|
|Study Start Date :||September 2005|
|Study Completion Date :||July 2006|
- Patient acceptability
- Voice analysis
- Quality of life
- Economic assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334997
|Bristol, England, United Kingdom, BS10 5NB|
|Aintree University Hospital|
|Liverpool, England, United Kingdom, L9 7AL|
|Clatterbridge Centre for Oncology|
|Merseyside, England, United Kingdom, CH63 4JY|
|James Cook University Hospital|
|Middlesbrough, England, United Kingdom, TS4 3BW|
|Norfolk and Norwich University Hospital|
|Norwich, England, United Kingdom, NR4 7UY|
|Royal Infirmary - Castle|
|Glasgow, Scotland, United Kingdom, G4 0SF|
|Study Chair:||Martin A. Birchall, MD||Southmead Hospital|