Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Feasibility
Safety Issue:
No
Principal Investigator
Martin A. Birchall, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Southmead Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000478790
NCT ID:
NCT00334997
Start Date:
September 2005
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage I squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the larynx
- stage 0 laryngeal cancer
- Laryngeal Neoplasms
- Head and Neck Neoplasms
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