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
  Purpose

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.


Condition Intervention
Cancer of the Head and Neck
Other: 18F-FAZA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Can 18F-FAZA can be used as a prognostic marker in HNSCC? [ Time Frame: 1, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

tissue


Enrollment: 40
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 18F-FAZA
    PET scan
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

head and neck cancer patients

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01017224

Locations
Denmark
Department of Oncology, Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
Danish Head and Neck Cancer Group
Investigators
Principal Investigator: Jens Overgaard, Prof., MD Danish Head and Neck Cancer Group (DAHANCA)
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01017224     History of Changes
Other Study ID Numbers: DAHANCA 24
Study First Received: November 19, 2009
Last Updated: May 11, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on July 22, 2014