Head and Neck Cancer Clinical Trial
Official title:
Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]
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 |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2006 |
Est. primary completion date | |
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 |
Allocation: Randomized, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
University College London Hospitals |
United Kingdom,
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 |
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