Trial of Induction TPF therapy in Advanced head & Neck cancer
| ISRCTN | ISRCTN74465582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74465582 |
| EudraCT/CTIS number | 2010-023195-22 |
| Secondary identifying numbers | 10000 |
- Submission date
- 10/08/2011
- Registration date
- 10/08/2011
- Last edited
- 23/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Miss Gemma Simpson
Scientific
Scientific
University of Liverpool Cancer Research Centre
200 London Road
Liverpool
L3 9TA
United Kingdom
Study information
| Study design | Randomised, interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not provided at time of registration |
| 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 acronym | TITAN |
| Study objectives | 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(s) | First MREC, 11/04/2011, ref: 11/NW/0149 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Taxane, cisplatin, 5-fluorouracil |
| Primary outcome measure | 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 study start date | 01/09/2011 |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 50 |
| Total final enrolment | 7 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 01/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Liverpool Cancer Research Centre
Liverpool
L3 9TA
United Kingdom
L3 9TA
United Kingdom
Sponsor information
Aintree University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Aintree University Hospitals
Fazakerley Hospital
Lower Lane
Liverpool
L9 7AL
England
United Kingdom
| Website | http://www.aintreehospitals.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02h67vt10 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 23/06/2020 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/06/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
04/07/2017: No publications found in PubMed, verifying study status with principal investigator.
