ClinicalTrials.gov processed this data on March 29, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00334997CDR0000478790CRUK-BRD/05/024EU-20611CRUK-EASTERISRCTN17541410NCT00334997Endoscopic Surgery or Radiation Therapy in Treating Patients With Stage 0, Stage I, or Stage II Laryngeal Cancer of the GlottisEarly Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]University College London HospitalsOther
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.
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.
CompletedSeptember 2005July 2006Phase 2InterventionalNoRandomizedTreatmentFeasibilityPatient acceptabilityVoice analysisQuality of lifeEconomic assessment50Head and Neck CancerProcedureendoscopic surgeryProcedurelaser surgeryRadiationradiation therapy
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
All18 YearsN/ANoMartin A. Birchall, MDStudy ChairSouthmead HospitalSouthmead HospitalBristolEnglandBS10 5NBUnited KingdomAintree University HospitalLiverpoolEnglandL9 7ALUnited KingdomClatterbridge Centre for OncologyMerseysideEnglandCH63 4JYUnited KingdomJames Cook University HospitalMiddlesbroughEnglandTS4 3BWUnited KingdomNorfolk and Norwich University HospitalNorwichEnglandNR4 7UYUnited KingdomRoyal Infirmary - CastleGlasgowScotlandG4 0SFUnited KingdomUnited KingdomMarch 2009June 7, 2006June 7, 2006June 8, 2006December 18, 2013December 18, 2013December 19, 2013stage I squamous cell carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage 0 laryngeal cancer