Condition category
Cancer
Date applied
10/08/2011
Date assigned
10/08/2011
Last edited
10/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Gemma Simpson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2010-023195-22

ClinicalTrials.gov number

Protocol/serial number

10000

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

Acronym

TITAN

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not provided at time of registration

Condition

Head and neck cancer

Intervention

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

Drug

Phase

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

01/09/2011

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/09/2011

Recruitment end date

01/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool Cancer Research Centre
Liverpool
L3 9TA
United Kingdom

Sponsor information

Organisation

Aintree University Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.aintreehospitals.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

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