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| ID | Type | Description | Link |
|---|---|---|---|
| CRUK-BRD/05/024 | |||
| EU-20611 | |||
| CRUK-EASTER | |||
| ISRCTN17541410 |
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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.
OBJECTIVES:
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic surgery | Procedure | |||
| laser surgery | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | ||
| Patient acceptability |
| Measure | Description | Time Frame |
|---|---|---|
| Voice analysis | ||
| Quality of life | ||
| Economic assessment |
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DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the glottic larynx, including tumors at the anterior commissure
No clinical or radiological sign of nodal involvement
No evidence of distant metastases
Airway anatomy suitable for endoscopic excision
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Martin A. Birchall, MD | Southmead Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southmead Hospital | Bristol | England | BS10 5NB | United Kingdom | ||
| Aintree University Hospital |
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| Liverpool |
| England |
| L9 7AL |
| United Kingdom |
| Clatterbridge Centre for Oncology | Merseyside | England | CH63 4JY | United Kingdom |
| James Cook University Hospital | Middlesbrough | England | TS4 3BW | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | England | NR4 7UY | United Kingdom |
| Royal Infirmary - Castle | Glasgow | Scotland | G4 0SF | United Kingdom |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010039 | Otorhinolaryngologic Neoplasms |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D053685 | Laser Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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