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| A multicentre randomised phase III trial comparing Positron Emission Tomography - computed tomography guided watch and wait policy versus planned NECK dissection for the management of locally advanced (N2/N3) nodal metastases in patients with head and neck squamous cancer |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN13735240 |
| Date ISRCTN assigned | 12/06/2007 |
| Local reference number(s) | HTA 06/302/129; PET-NECK V1.0 5Feb07 |
| Public title | A multicentre randomised phase III trial comparing Positron Emission Tomography - computed tomography guided watch and wait policy versus planned NECK dissection for the management of locally advanced (N2/N3) nodal metastases in patients with head and neck squamous cancer |
| Scientific title | |
| Acronym | PET-CT |
| Disease/condition/study domain | Head and neck squamous cell carcinoma (HNSCC) |
| Study hypothesis | Head and Neck Squamous Cell Carcinoma (HNSCC) is the sixth most common cancer worldwide with approximately 500,000 new cases/year. It poses a significant therapeutic problem as it has a high mortality and morbidity and survival rates have not considerably improved over the past two decades despite newer aggressive surgical and chemoradiotherapy (CRT) regimens. CRT is the preferred first line of treatment for several types of HNSCC. For patients with large metastasis to the neck nodes, evidence for management is sparse. Current standard care is neck dissection either before/after CRT. There is debate regarding whether a neck dissection is needed or whether CRT alone is sufficient. Controversy continues mainly due to poor quality and contradictory evidence from prospective and retrospective case series for both management strategies. Furthermore the advent of newer, more accurate functional modalities for the detection of persistent disease, e.g., Positron Emission Tomography - Computed Tomography (PET-CT) scanning have further strengthened this debate. Aim: To test the hypotheses that a PET-CT guided watch and wait policy (experimental arm) is non-inferior to the current practice of planned neck dissection (control arm) when comparing overall and disease-specific survival in the management of advanced (N2 or N3) nodal metastasis in patients treated with CRT for their HNSCC primary. Recurrence, quality of life and cost effectiveness will be assessed as secondary outcomes. |
| Design/methodology | Two-arm multi-centre randomised trial. Randomisation 1:1 with stratification (centre, chemotherapy schedule, N stage, T stage). |
| Research ethics review | Approval received from the Oxford Research Ethics Committee A on the 9th May 2007 (ref: 07/Q1604/35). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histological diagnosis of oropharyngeal, laryngeal, oral or hypopharyngeal 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 |
| Participants - exclusion criteria | 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 with occult nodal metastasis, i.e., large nodal metastasis but no proven primary site on clinical assessment 11. Pregnant patients 12. Patients under 18 years of age |
| Patient information material | |
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 31/03/2013 |
| Status of trial | Ongoing |
| Target number of participants | 560 |
| 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 regimen must be: 1. A CRT schedule that the centre uses in their normal, peer-reviewed practice AND 2. The CRT schedule selected must be present in the list of approved trial schedules The recommended standard radiotherapy schedule for the trial is radiotherapy doses of 65 to 70 Gy in 30 to 35 daily fractions of 2 Gy or more with at least two doses of concomitant three/four weekly intravenous cisplatin 75 to 100 mg/m^2 or carboplatin (4.5 to 5 AUC). Control arm: planned pre-CRT neck dissections - neck dissections must be performed within two to four weeks of randomisation. The recommended surgical procedure is a modified radical neck dissection This involves removal of lymphatic structures in levels I-V, with preservation of one or more of the following: spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle. Experimental arm: PET-CT scan Both groups will be followed up for two years. |
| Primary outcome measure(s) | 1. Overall survival, measured at at two years 2. Health economics (Quality Adjusted Life Years [QALYs]), measured at at two years |
| Secondary outcome measure(s) | 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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University Hospitals Coventry and Warwickshire NHS Trust (UK) |
| Sponsor details | University of Warwick Clifford Bridge Road Coventry United Kingdom CV2 2DX |
| Sponsor telephone | +44 (0)2476 964 000 |
| Sponsor email | ceri.jones@uhcw.nhs.uk |
| Sponsor website | http://www.uhcw.nhs.uk/ |
| Contact name | Mr Hisham Mehanna |
| Contact details | University Hospitals Coventry and Warwickshire NHS Trust Clifford Bridge Road Coventry United Kingdom CV2 2DX |
| Contact telephone | +44 (0)2476 965 606 |
| Contact fax | +44 (0)2476 965 613 |
| Contact email | hisham.mehanna@uhcw.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN13735240 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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