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THE CLINICAL VALUE OF COMBINED FDG PET/CT IMAGING IN RESPONSE EVALUATION AFTER RADIOCHEMOTHERAPY IN PATIENTS WITH POTENTIALLY OPERABLE LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA

Completed
Conditions
head and neck cancer
head and neck squamous cell carcinoma
10038666
Registration Number
NL-OMON36288
Lead Sponsor
Vrije Universiteit Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

operable N2/N3 squamous cell carcinoma of head and neck
planned treatment of chemoradiation (with curative intent)

Exclusion Criteria

Age < 18 years
Pregnancy
Physical condition contra-indication for neck dissection
Inoperable tumour in neck

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The negative predictive value (NPV) of FDG PET/CT for detecting residual nodal<br /><br>involvement</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1. The sensitivity and specificity of high-resolution FDG PET/CT<br /><br>2. The sensitivity and specificity of dual time point FDG PET/CT<br /><br>3. The number of additional distant metastases found on PET and the % change in<br /><br>patient management<br /><br>4. DFS and OS, correlation with baseline SUV, early PET response and with HPV<br /><br>status</p><br>
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