Status:

COMPLETED

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

Lead Sponsor:

University College London Hospitals

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 cell...

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 t...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    July 1 2006

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00334997

    Start Date

    September 1 2005

    End Date

    July 1 2006

    Last Update

    December 19 2013

    Active Locations (6)

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    Page 1 of 2 (6 locations)

    1

    Southmead Hospital

    Bristol, England, United Kingdom, BS10 5NB

    2

    Aintree University Hospital

    Liverpool, England, United Kingdom, L9 7AL

    3

    Clatterbridge Centre for Oncology

    Merseyside, England, United Kingdom, CH63 4JY

    4

    James Cook University Hospital

    Middlesbrough, England, United Kingdom, TS4 3BW