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

niversity Hospitals Coventry and Warwickshire NHS Trust (UK)0 个研究点目标入组 560 人开始时间: 2007年6月12日最近更新: 2022年4月4日

适应症

试验速览

•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

•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

发起方

niversity Hospitals Coventry and Warwickshire NHS Trust (UK)