Head and neck squamous cell carcinoma (HNSCC) Cancer Squamous cell carcinoma
Conditions
Interventions
CRT regimens:
All patients must receive concomitant CRT to be included in the trial. For each patient, the participating centre must specify the schedule that they will use. This regim
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of oropharyngeal, laryngeal, oral, hypopharyngeal or occult HNSCC 2. Clinical and CT/Magnetic Resonance Imaging (MRI) evidence of nodal metastases staged N2 (a, b or c) or N3 3. Indication to receive curative radical concurrent CRT for primary 4. Fitness for neck dissection surgery
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/01/2011: 1. Patients undergoing resection for their primary tumour, e.g., resection of tonsil or base of tongue with flap reconstruction (diagnostic tonsillectomy not considered an exclusion criteria) 2. Patients with N1 nodal metastasis 3. Patients receiving neo-adjuvant chemoradiotherapy with no concomitant chemotherapy 4. Patients receiving adjuvant chemotherapy 5. Patients undergoing chemo +/- radiotherapy for palliative purposes 6. Patient undergoing radiotherapy alone (not optimal treatment for neck node disease) 7. Distant metastases to chest, liver, bones or other sites 8. Unfit for surgery or chemoradiotherapy 9. Previous treatment for head and neck squamous cell carcinoma 10. Patients have had another cancer diagnosis in the last five years (except basal cell carcinoma or carcinoma of the cervix in situ). 11. Pregnant patients 12. Patients under 18 years of age Previous exclusion criteria: 10. Patients with occult nodal metastasis, i.e., large nodal metastasis but no proven primary site on clinical assessment
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease-specific survival, measured at pre-treatment and 3, 6, 12 and 24 months post randomisation 2. Recurrence in the neck, measured at pre-treatment and 3, 6, 12 and 24 months post randomisation 3. Quality of life, measured at pre-treatment and 3, 6, 12 and 24 months post randomisation 4. Complication rates, measured at pre-treatment and 3, 6, 12 and 24 months post randomisation 5. Accuracy of PET-CT scanning for assessing the primary tumour | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Overall survival, measured at at two years 2. Health economics (Quality Adjusted Life Years [QALYs]), measured at at two years | — |
Countries
England, United Kingdom
Outcome results
None listed