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

Sponsored by:	University College London Hospitals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00334997

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 II

MedlinePlus related topics: Cancer Endoscopy Head and Neck Cancer Radiation Therapy Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Early Stage Glottic Cancer: Endoscopic Excision or Radiotherapy [EaStER]

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, England
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
Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
United Kingdom, Scotland
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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Respiratory Tract Diseases
Laryngeal Carcinoma
Head and Neck Neoplasms
Epidermoid Carcinoma

Laryngeal Neoplasms
Laryngeal Diseases
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Otorhinolaryngologic Diseases
Neoplasms by Site
Otorhinolaryngologic Neoplasms

Respiratory Tract Diseases
Head and Neck Neoplasms
Laryngeal Neoplasms
Laryngeal Diseases

ClinicalTrials.gov processed this record on May 06, 2009