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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334997
• Other study ID #: CDR0000478790
• Secondary ID: CRUK-BRD/05/024E
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2006
• Last updated: December 18, 2013
• Start date: September 2005
• Est. completion date: July 2006

Study information

• Verified date: March 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• endoscopic surgery

• laser surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Southmead Hospital	Bristol	England
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility			No
Primary	Patient acceptability			No
Secondary	Voice analysis			No
Secondary	Quality of life			No
Secondary	Economic assessment			No