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

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT01017224
Collaborator
Danish Head and Neck Cancer Group (Other)
40
Enrollment
1
Location
30
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 18F-FAZA

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
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
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Outcome Measures

Primary Outcome Measures

  1. Can 18F-FAZA can be used as a prognostic marker in HNSCC? [1, 5 years]

Secondary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01017224
Other Study ID Numbers:
  • DAHANCA 24
First Posted:
Nov 20, 2009
Last Update Posted:
May 14, 2012
Last Verified:
May 1, 2012
Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Fluoroazomycin arabinoside

Study Results

No Results Posted as of May 14, 2012