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NCT Number: NCT00334997

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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southmead Hospital, Bristol, England, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic surgery

Procedure

laser surgery

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Feasibility

  2. Patient acceptability

Secondary outcomes

  1. Voice analysis

  2. Quality of life

  3. Economic assessment

Sponsors and collaborators

Lead sponsor

University College London Hospitals

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Jun 8, 2006
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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