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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00334997
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Procedure: endoscopic surgery Procedure: laser surgery Radiation: radiation therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]
Study Start Date : September 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Primary Outcome Measures :
  1. Feasibility
  2. Patient acceptability

Secondary Outcome Measures :
  1. Voice analysis
  2. Quality of life
  3. Economic assessment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • No concurrent chemotherapy
  • No concurrent palliative treatment

Information from the National Library of Medicine

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 identifier (NCT number): NCT00334997

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United Kingdom
Southmead Hospital
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
Sponsors and Collaborators
University College London Hospitals
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Study Chair: Martin A. Birchall, MD Southmead Hospital
Layout table for additonal information Identifier: NCT00334997    
Other Study ID Numbers: CDR0000478790
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: March 2009
Keywords provided by National Cancer Institute (NCI):
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage 0 laryngeal cancer