Re-irradiation in Recurrent and Second Primary Head and Neck CancerNCT01427010
A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.
A study testing [18F]FDG-PET-voxel intensity-based IMRT in people with Re-irradiation in Recurrent and Second Primary Head and Neck Cancer, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also be of importance in IMRT for recurrent and second primary head and neck cancers in previously irradiated territory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Re-irradiation in Recurrent and Second Primary Head and Neck Cancer
- What is being tested?
- [18F]FDG-PET-voxel intensity-based IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2012to Aug 2015
- Phase
- Interventional
- 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
- Histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory.
- Primary unresectable tumor and/or patients refused surgery.
- No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer.
- Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer.
- Decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab)
- Karnofsky performance status ≥70%.
- Age ≥ 18 years old.
- Informed consent obtained, signed and dated before specific protocol procedures.
Who cannot join
- Previous radiotherapy for cT1-2 cN0 M0 glottic cancer.
- Brachytherapy as treatment for second primary / recurrence.
- Distant metastases.
- Other second primary tumors that are not under control.
- Pregnant or lactating women.
- Elevated blood creatinine level.
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- Allergy to the CT-contrast agents.
- Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Antwerp University Hospital
Antwerp
University Hospital Ghent
Ghent, 9000
About this study
Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also be of importance in IMRT for recurrent and second primary head and neck cancers in previously irradiated territory.
This trial investigates the feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel ([18F]FDG-PET-voxel) intensity-based IMRT in reirradiation of patients with recurrent and second primary head and neck cancer.
- Being tested
- [18F]FDG-PET-voxel intensity-based IMRT
- 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]FDG-PET-voxel intensity-based IMRTRadiation
Non-controlled, non-randomized, prospective study on 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-voxel intensity-based intensity-modulated radiotherapy (IMRT) (dose painting) adapted to the anatomical and biological changes as detected by per-treatment FDG-PET/Computertomography (CT) acquired at the end of the 2nd and the 4th week of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Reirradiation of recurrent and 2nd primary head/neck cancer. | Experimental | Not described Receives: Radiation: [18F]FDG-PET-voxel intensity-based IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test success rate of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy).
To test feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy) in treatment of recurrent and second primary head and neck cancer in the previously irradiated territory.
Measured: 2 year
Secondary outcomes (3)
Estimation time to progression.
Measured: At 6, 9 and 12 months
Evaluation tumor response.
Measured: After 3 months.
Number of Participants with Adverse Events.
Evaluation acute toxicity.
Measured: Up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Re-irradiation in Recurrent and Second Primary Head and Neck CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilfried De Neve, Ph.D., M.D., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427010
- Sponsor's protocol ID
- 2011/536
- Status last verified
- Apr 2018
- First submitted
- 29 Aug 2011
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.
- ClinicalTrials.gov ID
- NCT01427010
- Acronym / sponsor ID
- 2011/536
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Sep 2011 (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.
Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also be of importance in IMRT for recurrent and second primary head and neck cancers in previously irradiated territory.
This trial investigates the feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel ([18F]FDG-PET-voxel) intensity-based IMRT in reirradiation of patients with recurrent and second primary head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Reirradiation of recurrent and 2nd primary head/neck cancer. | Experimental | Radiation: [18F]FDG-PET-voxel intensity-based IMRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory.
- Primary unresectable tumor and/or patients refused surgery.
- No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer.
- Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer.
- Decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab)
Key exclusion criteria (9 listed)
- Previous radiotherapy for cT1-2 cN0 M0 glottic cancer.
- Brachytherapy as treatment for second primary / recurrence.
- Distant metastases.
- Other second primary tumors that are not under control.
- Pregnant or lactating women.
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]FDG-PET-voxel intensity-based IMRTNon-controlled, non-randomized, prospective study on 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-voxel intensity-based intensity-modulated radiotherapy (IMRT) (dose painting) adapted to the anatomical and biological changes as detected by per-treatment FDG-PET/Computertomography (CT) acquired at the end of the 2nd and the 4th week of treatment. | Radiation | Reirradiation of recurrent and 2nd primary head/neck cancer. |
Primary outcome
To test success rate of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy).
Time frame: 2 year
To test feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy) in treatment of recurrent and second primary head and neck cancer in the previously irradiated territory.
3 secondary outcomes
Estimation time to progression.
Time frame: At 6, 9 and 12 months
Evaluation tumor response.
Time frame: After 3 months.
Number of Participants with Adverse Events.
Time frame: Up to 3 months.
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 19 Apr 2018.
- Related InfoLink provided by the sponsor.
Related trials for Re-irradiation in Recurrent and Second Primary Head and Neck Cancer
Active, not recruitingPhase 2
SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma
Head and Neck Squamous Cell Carcinoma (HNSCC)
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, Ph.D., M.D. principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]FDG-PET-voxel intensity-based IMRT in people with Re-irradiation in Recurrent and Second Primary Head and Neck Cancer, run by University Hospital, Ghent at 2 sites 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 8 inclusion and 9 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 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
To test success rate of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy). (time frame: 2 year). 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 19 Apr 2018.