Endoscopic Surgery or Radiation Therapy in Treating Patients With Stage 0, Stage I, or Stage II Laryngeal Cancer of the Glottis
NCT ID: NCT00334997
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2005-09-30
2006-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
endoscopic surgery
laser surgery
radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University College London Hospitals
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin A. Birchall, MD
Role: STUDY_CHAIR
Southmead Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southmead Hospital
Bristol, England, 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, United Kingdom
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRUK-BRD/05/024
Identifier Type: -
Identifier Source: secondary_id
EU-20611
Identifier Type: -
Identifier Source: secondary_id
CRUK-EASTER
Identifier Type: -
Identifier Source: secondary_id
ISRCTN17541410
Identifier Type: -
Identifier Source: secondary_id
CDR0000478790
Identifier Type: -
Identifier Source: org_study_id