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

NCT00334997 | Completed Phase 2

• 5 other identifiers: CDR0000478790CRUK-BRD/05/024EU-20611CRUK-EASTERISRCTN17541410
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the larynx; stage 0 laryngeal cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility

• Patient acceptability

Secondary Outcomes (3)

• Voice analysis

• Quality of life

• Economic assessment

Interventions

endoscopic surgery PROCEDURE

laser surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (6)

Southmead Hospital

Bristol, England, BS10 5NB, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Laryngeal Neoplasms

Interventions

Endoscopy; Laser Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Therapeutics; Ablation Techniques

Study Officials

• Martin A. Birchall, MD

  Southmead Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 8, 2006
• Study Start: September 1, 2005
• Study Completion: July 1, 2006
• Last Updated: December 19, 2013

Record last verified: 2009-03

Locations

GB (6)