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ISRCTN
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ISRCTN89530459
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ClinicalTrials.gov identifier
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Public title
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Fluorodeoxyglucose-positron emission tomography for avoidance of futile direct laryngoscopies under general anaesthesia with taking of biopsies in patients with suspicion on recurrent laryngeal carcinoma after radiotherapy
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Scientific title
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Acronym
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RELAPS: REcurrent LAryngeal carcinoma PET Study
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Serial number at source
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ZonMw: 945-04-311 2004/036 (projectnummer VUmc); NTR93
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised, active controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Laryngeal carcinoma
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Participants - inclusion criteria
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1. Patients with clinical suspicion on recurrent laryngeal carcinoma after radiotherapy (without obvious signs of tumour), in whom a direct laryngoscopy under general anaesthesia with taking of biopsies is indicated
2. T2 - T4 laryngeal carcinoma
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Participants - exclusion criteria
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1. Aged less than 18 years
2. Pregnancy
3. Radiotherapy within the last four months
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Anticipated start date
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01/02/2005
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Anticipated end date
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30/06/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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150
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Interventions
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Selection for direct laryngoscopy with fluorodeoxyglucose-positron emission tomography (FDG-PET). Two strategy arms are compared:
1. Conventional strategy: direct laryngoscopy under general anaesthesia with taking of biopsies
2. PET based strategy: only direct laryngoscopy under general anaesthesia with taking of biopsies if FDG-PET is positive or equivocal
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Primary outcome measure(s)
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Number of direct laryngoscopies (on a group level) needed to detect (a single) recurrent laryngeal carcinoma.
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Secondary outcome measure(s)
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Key:
1. Costs
2. Operability of a recurrence
3. Surgical margins of the salvage laryngectomy
4. Quality of life
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
R
de Bree
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Address
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Boelelaan 1117
Department of Otolaryngology /Head and Neck Surgery
Vrije University Medical Centre
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City/town
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Amsterdam
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Zip/Postcode
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1081 HV
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Country
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Netherlands
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Tel
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+31 (0)20 444 3690
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Fax
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+31 (0)20 444 3688
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Email
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r.bree@vumc.nl
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Sponsor
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Vrije University Medical Centre (VUMC) (The Netherlands)
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Address
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Van der Boechorststraat 7
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City/town
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Amsterdam
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Zip/Postcode
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1081 BT
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Country
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Netherlands
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Sponsor website:
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http://www.vumc.nl/english/
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Date applied
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12/09/2005
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Last edited
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19/09/2008
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Date ISRCTN assigned
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12/09/2005
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