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

Phase 3

Completed

• Conditions: Head and neck squamous cell carcinoma (HNSCC); Cancer; Squamous cell carcinoma

• Registration Number: ISRCTN13735240
• Lead Sponsor: niversity Hospitals Coventry and Warwickshire NHS Trust (UK)

Brief Summary

2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27007578 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28409743 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-12
• Study Completion: 2015-03-31
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 560

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified