Cancer of the Head and NeckNCT01017224
DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)
An observational study of Cancer of the Head and Neck, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck
- What is being tested?
- 18F-FAZA
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: head and neck cancer patients
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Aarhus University Hospital
Aarhus, Aarhus, DK-8000
About this study
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
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.
Read more
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.
- Conditions
- Cancer of the Head and Neck
- Being tested
- 18F-FAZA
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAZAOther
PET scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Can 18F-FAZA can be used as a prognostic marker in HNSCC?
Measured: 1, 5 years
Secondary outcomes (1)
Determine the changes in hypoxia in solid tumours as assessed by 18F-FAZA PET during radiotherapy
Measured: Patients will be scanned prior to treatment, every 2 weeks during their treatment and once following radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Head and Neck Cancer Group
- Responsible party
- Sponsor
- Investigators
- Jens Overgaard, Prof., MD, Principal investigator, Danish Head and Neck Cancer Group (DAHANCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017224
- Sponsor's protocol ID
- DAHANCA 24
- Status last verified
- May 2012
- First submitted
- 19 Nov 2009
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01017224
- Acronym / sponsor ID
- DAHANCA 24
- Conditions
- Cancer of the Head and Neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Head and Neck Cancer Group
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- head and neck cancer patients
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FAZAPET scan | Other | – |
Primary outcome
Can 18F-FAZA can be used as a prognostic marker in HNSCC?
Time frame: 1, 5 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Overgaard, Prof., MD principal investigator
Danish Head and Neck Cancer Group (DAHANCA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Head and Neck, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can 18F-FAZA can be used as a prognostic marker in HNSCC? (time frame: 1, 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2012.