Trial of Induction TPF therapy in Advanced head & Neck cancer

Phase 2

Completed

• Conditions: Head and neck cancer; Cancer; Malignant neoplasm of head, face and neck

• Registration Number: ISRCTN74465582
• Lead Sponsor: Aintree University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-10
• Study Completion: 2011-09-01
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified