Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Miss Gemma Simpson


Contact details

University of Liverpool Cancer Research Centre
200 London Road
L3 9TA
United Kingdom

Additional identifiers

EudraCT number

2010-023195-22 number

Protocol/serial number


Study information

Scientific title

Randomised controlled open-label trial of TPF (taxane cisplatin 5-fluorouracil) induction chemotherapy in the surgical management of locally advanced head and neck cancer



Study hypothesis

This is a trial of treatment intensification in a high-risk population of potentially curable patients. Induction chemotherapy is a significant recent advance in the management of locally advanced squamous cell carcinoma of the head and neck (SCCHN), although its use in combination with surgery and postoperative radiotherapy (PORT) is under-researched. Induction chemotherapy (ICT) offers the potential for better delivery of drugs to "treatment naïve" tumours with an intact blood supply and, at the same time, provides maximal treatment to eradicate micro-metastasis, with the prospect of both better local and local systemic control of disease.

Thus the rationale is to study the effects of intensification of treatment using induction TPF in locally advanced SCCHN in those anatomical sites treated by primary surgery.

Ethics approval

First MREC, 11/04/2011, ref: 11/NW/0149

Study design

Randomised, interventional

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not provided at time of registration


Head and neck cancer


Patients will be randomised in a 1:1 ratio across 2 arms

Arm A: surgery and post operative conformal radiation therapy (CRT) (PO(C)RT)
Conventional treatment for the stage and site of disease is performed as per the original (pre-randomisation) imaging, examination under anaesthetic and clinical findings.

Arm B: Induction Chemotherapy
Patients will recieve 3 cycles of induction chemotherapy at 21 days intervals, prior to recieving surgery and PO(C)RT

To be followed up at 60 month(s)

Intervention type



Phase II/III

Drug names

Taxane, cisplatin, 5-fluorouracil

Primary outcome measures

Feasibility of recruitment into the TITAN trial (specifically the number of participants)

Secondary outcome measures

1. Randomisation: screening ratio
2. The percentage of patients in the TPF arm who complete the full course of treatment

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Age >18 years
2. Histopathological diagnosis of head and neck squamous cell carcinoma
3. Tumour (T) stage in one of the following site categories:
3.1. Lip/ Oral cavity: stage T3 or T4a (and >=4cm in largest dimension)
3.2. Paranasal /nasal: stage T4a
3.3. Larynx: stage T4a
3.4. Hypopharynx: stage T3 or T4a
3.5. Cervical oesophagus: stage T3 or T4a
3.6. Oropharynx: stage T3 or T4a and HPV-ve
4. Any lymph node (N) stage
5. No metastases (M0)
6. An multidisciplinary team (MDT) decision to offer surgery as primary modality of treatment
7. World Health Organisation (WHO) performance status 0 or 1
8. Resectable by conventional criteria in both primary site and any cervical lymph node involvement
9. Male or female paticipants
10. Lower age limit: 18 years

Participant type


Age group




Target number of participants

UK Sample Size: 50

Participant exclusion criteria

1. Those tumours staged to T4a on the basis of early mandibular invasion alone, i.e. <4cm in the maximum dimension
2. Unresectable disease on clinical staging (including imaging) of primary tumour or cervical metastasis
3. Distant metastases (note: positron emission tomography - computed tomography [PET-CT] is necessary investigation for all patients entering trial - as such additional CT chest will usually not be required to exclude pulmonary or hepatic metastases)
4. Nasopharynx site
5. Human papillomavirus (HPV) - positive oropharyngeal cancer (OPC)
6. Pregnancy or lactation
7. Patients with haemoglobin of <10g/dl
8. Patients with neutrophil counts of <1.5 x 109/l.
9. Patients with thrombocyte counts of <100 x 109/l.
10. Patients with significant hepatic impairment (Bilirubin >1.5x upper limit of normal range; ALT >2.5x upper limit of normal range; ALP >5x upper limit of normal range)
11. Patients with significant renal impairment (For the purpose of the study, significant renal impairment is classed as GFR <50ml/min>. However, sites may use their local policy if a higher threshold is dictated.)
12. Patients who lack mental capacity to give informed consent
13. Patients whose co morbidities or concomitant medications otherwise preclude TPF chemotherapy
14. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool Cancer Research Centre
L3 9TA
United Kingdom

Sponsor information


Aintree University Hospitals NHS Foundation Trust (UK)

Sponsor details

Aintree University Hospitals
Fazakerley Hospital
Lower Lane
L9 7AL
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Cancer Research UK

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

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