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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00334997
First received: June 7, 2006
Last updated: March 5, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
 Procedure: endoscopic surgery
Procedure: laser surgery
Radiation: radiation therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]
  • Patient acceptability [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Voice analysis [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Economic assessment [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334997

Locations
United Kingdom
Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
Aintree University Hospital
Liverpool, England, United Kingdom, L9 7AL
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom, G4 0SF
Sponsors and Collaborators
University College London Hospitals
Investigators
Study Chair: Martin A. Birchall, MD Southmead Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00334997     History of Changes
Other Study ID Numbers: CDR0000478790, CRUK-BRD/05/024, EU-20611, CRUK-EASTER, ISRCTN17541410
Study First Received: June 7, 2006
Last Updated: March 5, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage 0 laryngeal cancer

Additional relevant MeSH terms:
Laryngeal Neoplasms
Head and Neck Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Neoplasms
 Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013