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

This study has been completed.
Sponsor:
Collaborator:
Danish Head and Neck Cancer Group
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01017224
First received: November 19, 2009
Last updated: May 11, 2012
Last verified: May 2012

November 19, 2009
May 11, 2012
November 2009
May 2012   (final data collection date for primary outcome measure)
Can 18F-FAZA can be used as a prognostic marker in HNSCC? [ Time Frame: 1, 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017224 on ClinicalTrials.gov Archive Site
Determine the changes in hypoxia in solid tumours as assessed by 18F-FAZA PET during radiotherapy [ Time Frame: Patients will be scanned prior to treatment, every 2 weeks during their treatment and once following radiation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)
DAHANCA 24: Prognostic Value of 18F-FAZA Positron Emission Tomography After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

tissue

Non-Probability Sample

head and neck cancer patients

Cancer of the Head and Neck
Other: 18F-FAZA
PET scan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01017224
DAHANCA 24
No
University of Aarhus
University of Aarhus
Danish Head and Neck Cancer Group
Principal Investigator: Jens Overgaard, Prof., MD Danish Head and Neck Cancer Group (DAHANCA)
University of Aarhus
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP