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

December 18, 2013 updated by: University College London Hospitals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Liverpool, England, United Kingdom, L9 7AL
        • Aintree University Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Norwich, England, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G4 0SF
        • Royal Infirmary - Castle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Feasibility
Patient acceptability

Secondary Outcome Measures

Outcome Measure
Quality of life
Voice analysis
Economic assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College London Hospitals

Investigators

  • Study Chair: Martin A. Birchall, MD, Southmead Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

June 7, 2006

First Submitted That Met QC Criteria

June 7, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDR0000478790
  • CRUK-BRD/05/024
  • EU-20611
  • CRUK-EASTER
  • ISRCTN17541410

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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