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TITAN   

Title

Trial of Induction TPF Therapy in Advanced Head & Neck Cancer.


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
II Treatment Closed 18 or over Aintree NHS Trust / University of Liverpool Eudract No: 2010-023195-22
Isrctn No: 74465582

Purpose

TITAN is a open-label randomized controlled trial conducted in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC).

Induction(TPF) chemotherapy is a significant recent advance in the management of locally advanced HNSCC, although its use in combination with surgery and postoperative radiotherapy(PORT) is under-researched.

TITAN address the potential survival advantage of TPF induction chemotherapy prior to surgery and radiotherapy for locally advanced resectable SCCHN.


Trial Lead Organisations

LCTU / CR-UK


Trial Start Date

02/11/2011


Trial Coordinator

Tony Coffey


Trial Coordinator Email Address

tony.coffey@liverpool.ac.uk


Trial Coordinator Contact No

0151 794 8929


Website Treatment  

Arm A is the control arm. This entails surgery, followed by post-operative radiotherapy / chemoradiotherapy

Arm B is the experimental arm. This entails a cycle of induction chemotherapy every 3 weeks for 3 cycles. Once recovered from the chemotherapy side effects, the patient will recieve surgery followed by post-operative radiotherapy / chemoradiotherapy

Trial Endpoints  

This is currently a feasibility study with an intention to progress to phase III if feasibility is demonstrated.


Primary Outcome  

The primary endpoint is the feasibility of recruitment into the TITAN trial (specifically the number of patients recruited from at least 4 centres during a 12 month period).


Secondary Outcomes  

  • Randomisation: Screening ratio.
  • The percentage of patients in the TPF arm who complete the full course of treatment (including post-operative radiotherapy/chemoradiotherapy).

Eligibility  

Patient will have a histopathological diagnosis of head and neck squamous cell carcinoma and a MDT decision to offer surgery as primary modality of treatment

UK: ENGLAND

  • Bradford, St. Luke's Hospital (Bradford) (James McCaul)
  • Bristol, Bristol Haematology and Oncology Centre (Matthew Beasley)
  • Leeds, St. James's University Hospital (Leeds) (Karen Dyker)
  • Liverpool, University Hospital Aintree (Terry Jones)
  • London, Guy's & St Thomas' Hospital (London) (Mark McGurk)
  • London, Imperial College (London) (Simon Stewart)
  • London, University College Hospital (London) (Martin Forster)
  • Plymouth, Plymouth Oncology Centre (Amy Roy)
  • Wirral, The Clatterbridge Cancer Centre (Wirral) (Aditya Shenoy)

UK: SCOTLAND

  • Glasgow, The Beatson West of Scotland Cancer Centre (Glasgow) (Mohammed Rizwallunah)

UK: WALES

  • Cardiff, Velindre Hospital (Cardiff) (Mererid Evans)

UK: ENGLAND

  • Coventry, University Hospital Coventry (Mehanna Hisham)
  • London, Royal Marsden Hospital (London) (Kevin Harrington)

UK: SCOTLAND

  • Edinburgh, Edinburgh Cancer Centre (Elizabeth Junor)