Clinical trial NCT01017224: DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)
Official title: DAHANCA 24: Prognostic Value of 18F-FAZA Positron Emission Tomography After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Head and Neck
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Head and Neck Cancer Group
First posted: 2009-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: head and neck cancer patients

Brief summary: Solid tumours contain varying degrees of hypoxia. Studies show hypoxia to be associated with poor local control and survival, as hypoxia is a cause of resistance to radio- and chemotherapy and the development of a more aggressive tumour.

Previous attempts to measure hypoxia have been biased because the techniques have been invasive, not repeatable or difficult to apply on a routine basis. There is great interest in trying to measure hypoxia in tumours as this could lead to individualized hypoxia-modifying therapy and prediction of treatment response. Additionally the investigators' knowledge of change in hypoxia over time is limited, but of great interest as individualised treatment, such as intensity-modulated radiation therapy (IMRT) is emerging.

18F-FAZA, appears promising. It is a nitroimidazole, which gets trapped in hypoxic cells and can be detected by a positron emission therapy (PET) scan. Compared to other nitroimidazoles, 18F-FAZA has superior biokinetics and thereby is believed to provide a faster and clearer image of hypoxia.

The investigators' hypothesis is that 18F-FAZA can be used as a prognostic marker in HNSCC.


Eligibility criteria: Inclusion Criteria:

* Histological proven squamous cell carcinoma of the pharynx, larynx, oropharynx and hypopharynx
* Curative intent and no prior treatment
* Age \>= 18 years
* stage T1-4 N0-N3 M0.
* Informed consent according to local guidelines and national law
* The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up
* Fertile women must use contraceptive devices (IUD or oral contraceptives)

Exclusion Criteria:

* No serious concurrent medical disease
* No metastasis
* No prior disease that can affect the treatment, evaluation or outcome of current disease
* No pregnant or breastfeeding woman

Primary outcomes:
measure: Can 18F-FAZA can be used as a prognostic marker in HNSCC?
timeFrame: 1, 5 years
Secondary outcomes:
measure: Determine the changes in hypoxia in solid tumours as assessed by 18F-FAZA PET during radiotherapy
timeFrame: Patients will be scanned prior to treatment, every 2 weeks during their treatment and once following radiation
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
Study officials:
affiliation: Danish Head and Neck Cancer Group (DAHANCA)
name: Jens Overgaard, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: