Contact information
Type
Scientific
Contact name
Dr R de Bree
ORCID ID
Contact details
Boelelaan 1117
Department of Otolaryngology /Head and Neck Surgery
Vrije University Medical Centre
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 3690
r.bree@vumc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
ZonMw: 945-04-311 2004/036 (projectnummer VUmc); NTR93
Study information
Scientific title
Acronym
RELAPS: REcurrent LAryngeal carcinoma PET Study
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Prevention
Patient information sheet
Condition
Laryngeal carcinoma
Intervention
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
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Fluorodeoxyglucose
Primary outcome measure
Number of direct laryngoscopies (on a group level) needed to detect (a single) recurrent laryngeal carcinoma.
Secondary outcome measures
Key:
1. Costs
2. Operability of a recurrence
3. Surgical margins of the salvage laryngectomy
4. Quality of life
Overall study start date
01/02/2005
Overall study end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
150
Participant exclusion criteria
1. Aged less than 18 years
2. Pregnancy
3. Radiotherapy within the last four months
Recruitment start date
01/02/2005
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Netherlands
Study participating centre
Boelelaan 1117
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|