Head & Neck and ENT Newsletter May 2015 Oromouth is now also closed to females aged 35-44 as we are fully recruited in this age group Accelerated - We have recruited 16 patients this month, which is the highest monthly figure to date. Thank you to all the head and neck surgeons for your help in achieving this Coast is now closed to recruitment for the head and neck tumour site group of patients Hawk -The 1 st patient has consented for pre- screening We are the 1 st in Europe! OTO-104 is now in follow-up and closed to recruitment
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Head & Neck and ENT
Newsletter May 2015
Oromouth is now also closed to
females aged 35-44 as we are fully
recruited in this age group
Accelerated - We have recruited 16 patients
this month, which is the highest monthly
figure to date.
Thank you to all the head and neck surgeons
for your help in achieving this
Coast is now closed to
recruitment for the head
and neck tumour site group
of patients
Hawk -The 1st patient
has consented for pre-
screening
We are the 1st in
Europe!
OTO-104 is now
in follow-up and
closed to
recruitment
Head & Neck and ENT
Newsletter May 2015
Acronym Details Recruitment
(month)
Recruitment
(total)
Accelerated
PI Prof. H Mehanna
Accelerated development of novel and personalised treatments using new
and repurposed therapeutic agents and individualised treatment selection
and monitoring 16 50
AMPACT2
PI Mr. P Monksfield
A TACTT3 study extension evaluating the safety of repeated quarterly
treatment cycles with AM-101 for acute peripheral tinnitus 0 4
ART DECO
PI Dr. P Sanghera
Investigating dose escalated IMRT in locally advanced laryngeal and
hypopharyngeal cancers without unacceptable toxicity increases 0 30
BUTTERFLY
PI Mr. P Monksfield
Post-market follow-up on the Cochlear™ Baha® Attract System
(magnetic bone conduction implant) for Baha surgery candidates 0 14
Cost Effectiveness of BAHA
PI Mr. P Monksfield
Assessing the benefit to patients of BAHA implantation and the cost
effectiveness of using this device within the NHS 0 238
TRIALS CURRENTLY OPEN
Head & Neck and ENT
Newsletter May 2015
Acronym Details Recruitment
(month)
Recruitment
(total)
De-ESCALaTE HPV
PI Dr. A Hartley
Determination of early and late toxicity events in treatment of HPV
positive oropharyngeal SCC using cetuximab vs. cisplatin 0 26
ElaTION
PI Prof. H Mehanna
A randomised study investigating study looking at the efficacy and cost
effectiveness of real time ultrasound elastography in the investigations
of thyroid nodules and the diagnosis of thyroid cancer 0 0
Hawk
PI Dr. J. Good
A phase II study of MEDI4736 monotherapy in patients with recurrent
or metastatic SCC who have progressed after second line platinum
treatment (PD-L1 positive) 0 0
HOPON
PI Mr. P Praveen
A randomised controlled trial investigating the use of hyperbaric
oxygen to prevent osteoradionecrosis of the irradiated mandible 0 11
IoN
PI Prof. H Mehanna
A phase II/III trial investigating the necessity of ablative radio-iodine for
treatment of low risk differentiated thyroid cancer patients 0 0
NIMRAD
PI Dr. A Hartley
A phase III trial determining whether HNSCC patients unsuitable for
cisplatin/cetuximab can benefit from nimorazole with standard RT 0 7
TRIALS CURRENTLY OPEN
Head & Neck and ENT
Newsletter May 2015
Acronym Details Recruitment
(month)
Recruitment
(total)
OROMOUTH
PI Mr. S Ahmed
Determining the prevalence of HPV in the mouth and oropharynx of the
tonsillectomy population using tonsils, oral fluid, blood and urine 3 191
QUIET
PI Miss. R Banga
A Balanced Randomised Placebo Controlled Double-blind Phase IIa
Study to Investigate the Efficacy and Safety of AUT00063 Versus
Placebo in Subjective Tinnitus. 2 13
RAPPER
PI Dr. A Hartley
Assessing the association between DNA polymorphisms and individual
patient variability in normal tissue radiation response and toxicity 0 25
SEND
PI Mr. P Praveen
Investigating the role of selective neck dissection for patients with early
oral SCC (T1/T2) and no clinical evidence of lymph node metastases 0 28
TACTT3
PI Mr. P Monksfield
A phase III trial to evaluate the efficacy of repeated AM-101
(esketamine hydrochloride) gel injections for acute peripheral tinnitus 0 13
TRIALS CURRENTLY OPEN
Head & Neck and ENT
Newsletter May 2015
Acronym Details
CompARE
PI Prof. H Mehanna
A phase III 4 arm randomised controlled trial comparing alternative regimens for escalating treatment of higher-risk
oropharyngeal cancer
Condor
PI Dr. A Kong
A phase II randomised study of MEDI4736 monotherapy, tremelimumab monotherapy and MEDI4736 in combination
with tremelimumab in patients with recurrent or metastatic SCC who have progressed after second line platinum
treatment (PD-L1 negative)
DAHANCA-21
PI Mr P Praveen
Hyperbaric oxygen treatment of mandibular osteoradionecrosis. A randomised, clinical study.
EORTC
PI Prof. H Mehanna
An international phase IV field study for the reliability and validity of the EORTC Head and Neck Cancer Module
H&N43
PENDING TRIALS
Head & Neck and ENT
Newsletter May 2015
Institute of Head and Neck Studies and Education (InHANSE) School of Cancer Sciences
Robert Aitken Building, 2nd Floor
University of Birmingham
B15 2TT, UK
www.inhanse.org
Thank you for your continued support!
Any comments or suggestions?
Please forward to [email protected]
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