Assessment of tumor hypoxia during radiotherapy course in locally advanced Head and Neck cancer with 18F-fluoroazomycin arabinoside (18F-FAZA)-PET-CT

Completed

Conditions: hoofd hals kanker
Hypoxia in locally advanced Head and Neck cancer
10027656

Registration Number: NL-OMON36574

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

* Intended curative primary (chemo)radiation for patients with locally advanced HNSCC.
* Age * 18 years.
* WHO performance status 0-2 (see appendix 1)
* Histological of cytological confirmation of HNSCC
* Locally advanced HNSCC (stage III-IV), TNM classification [8]
* Staging procedure should at least include CT-neck, MRI-neck and 18F-FDG-PET-scan
* Life expectancy of at least 6 months
* Planned for 35 x 2 Gy IMRT eventually with concomitant chemotherapy
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
* Before patient registration/randomisation, written informed consent must be given according to ICH/EU GCP, and national/local regulations.

Exclusion Criteria

Not fullfilling the inclusioncriteria

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tumour hypoxia prior and during the course of radiotherapy/chemoradiation using<br /><br>18F-FAZA PET-CT for locally advanced HNSCC<br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate tumour heterogeneity with 18F-FAZA PET-CT<br /><br><br /><br>More specifically, the following endpoints will be used:<br /><br>* SUV hypoxia prior to therapy (SUV max, SUV70%) [Research 18F-FAZA PET scan]<br /><br>* SUV hypoxia week 1 of therapy (SUV max, SUV70%) [Research 18F-FAZA PET scan]<br /><br>* SUV hypoxia week 2 of therapy (SUV max, SUV70%) [Research 18F-FAZA PET scan]<br /><br>* SUV hypoxia week 4 of therapy (SUV max, SUV70%) [Research 18F-FAZA PET<br /><br>scan]</p><br>