DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)

Cancer of the Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017224
• Other study ID #: DAHANCA 24
• Status: Completed
• Phase: N/A
• First received: November 19, 2009
• Last updated: May 11, 2012
• Start date: November 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

Other:
• 18F-FAZA
PET scan

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Danish Head and Neck Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Can 18F-FAZA can be used as a prognostic marker in HNSCC?		1, 5 years	No
Secondary	Determine the changes in hypoxia in solid tumours as assessed by 18F-FAZA PET during radiotherapy		Patients will be scanned prior to treatment, every 2 weeks during their treatment and once following radiation	No