Head and Neck NeoplasmsPhase 1NCT00135161
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
A Phase 1 study testing FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT). in people with Head and Neck Neoplasms, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2003to Aug 2015
- Phase
- Phase 1
- 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
Who may be able to join
- Patients with a proven histological squamous cell carcinoma of the larynx (only T3-4 NO or Tany N+), hypopharynx, oropharynx
- Patients who did not undergo surgery for the primary tumor location
- Patients with a Karnofsky performance score of 70% or more
- Written informed consent for participation in this trial
Who cannot join
- Other malignancy except for non-melanoma skin cancer
- Prior irradiation to the head and neck region
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).
Read the detailed description
The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard radiotherapeutic treatment for these types of cancers.
- Conditions
- Head and Neck Neoplasms
- Being tested
- FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
- Keywords
- neoplasms (squamous cell carcinoma of the head and neck region)
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).Procedure or surgery
FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).
| Study group | Role | What they receive |
|---|---|---|
| Intensity modulated radiation therapy (IMRT). | Experimental | Not described Receives: Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy
Measured: until 3 months after the end of the radiotherapy
Observation of chronic toxicity
Measured: until 3 months after the end of the radiotherapy
Secondary outcomes (3)
Therapy response (2-4 months after end of radiotherapy)
Measured: 2-4 months after end of radiotherapy
Local control at 2 years
Measured: at 2 years
Pattern of recurrence
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startSep 2003
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Federation Against Cancer
- Responsible party
- Sponsor
- Investigators
- Wilfried De Neve, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135161
- Sponsor's protocol ID
- 2003/202
- Status last verified
- Dec 2022
- First submitted
- 24 Aug 2005
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00135161
- Acronym / sponsor ID
- 2003/202
- Conditions
- Head and Neck Neoplasms
- Keywords
- neoplasms (squamous cell carcinoma of the head and neck region)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Belgian Federation Against Cancer
- Study start
- Sep 2003 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Aug 2005 (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.
The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).
Detailed description
The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard radiotherapeutic treatment for these types of cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensity modulated radiation therapy (IMRT). | Experimental | Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a proven histological squamous cell carcinoma of the larynx (only T3-4 NO or Tany N+), hypopharynx, oropharynx
- Patients who did not undergo surgery for the primary tumor location
- Patients with a Karnofsky performance score of 70% or more
- Written informed consent for participation in this trial
Key exclusion criteria (2 listed)
- Other malignancy except for non-melanoma skin cancer
- Prior irradiation to the head and neck region
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 |
|---|---|---|
| FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT). | Procedure or surgery | Intensity modulated radiation therapy (IMRT). |
Primary outcome
Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy
Time frame: until 3 months after the end of the radiotherapy
Observation of chronic toxicity
Time frame: until 3 months after the end of the radiotherapy
3 secondary outcomes
Therapy response (2-4 months after end of radiotherapy)
Time frame: 2-4 months after end of radiotherapy
Local control at 2 years
Time frame: at 2 years
Pattern of recurrence
Time frame: at 2 years
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 8 Dec 2022.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Wilfried De Neve, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT). in people with Head and Neck Neoplasms, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 2 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 8 Dec 2022. 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 Belgium. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy (time frame: until 3 months after the end of the radiotherapy). The study lists 2 primary outcomes in all. 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 8 Dec 2022.