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
| ISRCTN | ISRCTN89530459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89530459 |
| Protocol serial number | ZonMw: 945-04-311 2004/036 (projectnummer VUmc); NTR93 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 19/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R de Bree
Scientific
Scientific
Boelelaan 1117
Department of Otolaryngology /Head and Neck Surgery
Vrije University Medical Centre
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 444 3690 |
|---|---|
| r.bree@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | RELAPS: REcurrent LAryngeal carcinoma PET Study |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluorodeoxyglucose |
| Primary outcome measure(s) | Number of direct laryngoscopies (on a group level) needed to detect (a single) recurrent laryngeal carcinoma. |
| Key secondary outcome measure(s) | Key: 1. Costs 2. Operability of a recurrence 3. Surgical margins of the salvage laryngectomy 4. Quality of life |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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 |
| Key exclusion criteria | 1. Aged less than 18 years 2. Pregnancy 3. Radiotherapy within the last four months |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Boelelaan 1117
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
