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Clinical Trials/ISRCTN13735240
ISRCTN13735240
Completed
Phase 3

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 sites560 target enrollmentJune 12, 2007
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ConditionsHead and neck squamous cell carcinoma (HNSCC)CancerSquamous cell carcinoma

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Head and neck squamous cell carcinoma (HNSCC)
Sponsor
niversity Hospitals Coventry and Warwickshire NHS Trust (UK)
Enrollment
560
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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

Registry
who.int
Start Date
June 12, 2007
End Date
March 31, 2015
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospitals Coventry and Warwickshire NHS Trust (UK)

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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