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CompletedNCT00334997Updated Dec 19, 2013

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

A Phase 2 interventional study of endoscopic surgery and laser surgery in Head and Neck Cancer, sponsored by University College London Hospitals. Completed at 6 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-19.

Sponsored by University College London Hospitals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Head and Neck Cancer

Keywords

  • stage I squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the larynx
  • stage 0 laryngeal cancer
03

In context

Lead sponsor

University College London Hospitals is the lead sponsor of 61 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Enrollment
50 participants (estimated)

Interventions

  • Procedureendoscopic surgery
  • Procedurelaser surgery
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Feasibility

  2. Patient acceptability

Secondary outcomes

  1. Voice analysis

  2. Quality of life

  3. Economic assessment

07

Study locations

6 sites
  • Southmead Hospital
    Bristol, England BS10 5NB, United Kingdom
  • Aintree University Hospital
    Liverpool, England L9 7AL, United Kingdom
  • Clatterbridge Centre for Oncology
    Merseyside, England CH63 4JY, United Kingdom
  • James Cook University Hospital
    Middlesbrough, England TS4 3BW, United Kingdom
  • Norfolk and Norwich University Hospital
    Norwich, England NR4 7UY, United Kingdom
  • Royal Infirmary - Castle
    Glasgow, Scotland G4 0SF, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00334997
Lead sponsor
University College London Hospitals
First posted
Jun 8, 2006
Start date
Sep 2005
Completion
Jul 2006
Last update
Dec 19, 2013

Study contacts

Martin A. Birchall, MD
study chair · Southmead Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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