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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36574

Enrollment

Registered

2011-05-04

Start date

2011-11-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hoofd hals kanker Hypoxia in locally advanced Head and Neck cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Not fullfilling the inclusioncriteria

Design outcomes

Primary

Measure	Time frame
Tumour hypoxia prior and during the course of radiotherapy/chemoradiation using 18F-FAZA PET-CT for locally advanced HNSCC	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results