PET-NECK:
A multi-centre randomised phase III trial comparing a
PET-CT guided watch & wait policy versus planned neck dissection for the
management of locally advanced (N2/N3) nodal metastases in patients with head
& neck squamous cancer
Objectives
For further information please contact:
Joy K Rahman
Clinical Trials Co-ordinator
Warwick Clinical Trials Unit
Division of Health Sciences
Warwick Medical School
The University of Warwick
Coventry
CV4 7AL
PET NECK: Current treatment for patients with locally advanced head and
neck squamous cell carcinoma is neck dissection before or after chemoradiotherapy. This often results in high morbidity and mortality and
alternative and better management is needed. PET-NECK is a phase III
randomised controlled trial (560 patients) which is comparing PET-CT
guided watch and wait policy versus planned neck dissection for the
management of locally advanced head and neck cancer, in terms of:
• Efficacy (overall survival, disease-specific survival, local control)
• Cost-effectiveness (Health Resource use and Quality of Life)
• Safety (complications)
Schema
: +44 (0)2476 150 478
HEAD & NECK SCC CANCER DIAGNOSIS
: +44 (0)2476 150 586
: J.K.Rahman@warwick.ac.uk
KEY ELIGIBILITY CRITERIA
•Histological diagnosis of oropharyngeal, laryngeal, oral,
hypopharyngeal or occult HN SCC
•Clinical and CT/MRI evidence of N2 or N3 nodal metastases
•MDT decision for curative concurrent CRT to primary and neck
•Written consent and aged over 18
www.warwick.ac.uk/wms
Chief Investigator:
Professor Hisham Mehanna
University Hospitals Coventry &
Warwickshire
SURVEILLANCE ARM (280 Pts)
Standard concomitant CRT.
PET-CT & assessment 13 weeks
after CRT completion.
(Neck dissection only if neck nodes
are positive/equivocal).
CT & assessment after completion
of CRT.
PET-Neck Recruitment
600
500
400
479
300
200
100
Sep-12
May-12
Jan-12
Sep-11
May-11
Jan-11
Sep-10
May-10
Jan-10
Sep-09
May-09
Jan-09
Sep-08
May-08
Jan-08
0
Sep-07
Accrual duration: 5 years.
Target: 560 patients.
First patient randomised: October 2007.
Patients recruited: 479 as of 21/03/2012.
Planned close: September 2012.
Sites open to recruitment: 53.
Sites in set up: 4.
New sites: No longer open to new sites.
Local Sites Open: UHCW, Heartlands,
New Cross Wolverhampton, Manor
Hospital Walsall, QE Birmingham,
Russells Hall.
NECK DISSECTION ARM (280 Pts)
Standard concomitant CRT with
neck dissection (i.e. ND within 4
weeks of randomisation or 4 - 8
weeks after completion of CRT).
Portfolio Trial
Number: 6082