Condition category
Cancer
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
19/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Fluorodeoxyglucose

Primary outcome measures

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 trial start date

01/02/2005

Overall trial end date

30/06/2007

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.vumc.nl/english/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes