Locally Advanced Squamous Cell Carcinoma of the Head and Neck RegionECLYPSNCT01179360
Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
An observational study of Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region, run by University Hospital, Antwerp at 3 sites in 2 countries.
Trial summary
To determine if combined [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) is performant enough with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, N2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region
- What is being tested?
- Integrated FDG PET/CT
- How many people
- 152 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2011to Dec 2015
- 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: Patients with locally advanced, N2 and N3 HNSCC
Who may be able to join
- Patients with locoregionally advanced HNSCC (clinically and/or radiological N2 or N3 disease, any T stage) with no evidence of distant metastases, scheduled for concurrent chemoradiation and being potential candidates for a subsequent neck dissection.
- Induction chemotherapy is allowed if this approach is followed by concurrent chemo-radiation.
Who cannot join
- Other head and neck cancer histologies
- Upfront inoperable patients in the neck (eg. carotid invasion)
- Presence of distant metastases
- A history of another primary malignancy, except when disease-free for at least 5 years after radical treatment, or except for treated basaloid skin cancer or in situ carcinoma of the cervix
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
Antwerp University Hospital
Edegem, Antwerp, 2650
AZ Turnhout
Turnhout, Antwerp, 2300
Netherlands1 site
Academisch Ziekenhuis Vrije Universiteit Amsterdam
Amsterdam, 1081HV
About this study
Official title: Clinical Value of Combined [18F]Fluoro-2-deoxy-D-glucose (FDG) PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Potentially Operable Locally Advanced Head and Neck Squamous Cell Carcinoma.
To determine if combined [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) is performant enough with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, N2 and N3 head and neck squamous cell carcinoma (HNSCC).
Primary study hypothesis: The lower bound of the 95% confidence interval (CI) of the negative predictive value (NPV) of FDG PET/CT to detect residual malignant lymph node involvement at 12 weeks after completing chemoradiation will exceed 85%.
Read the detailed description
Patients with locally advanced, N2 and N3 head and neck squamous cell carcinoma (HNSCC) will be recruited. All subjects receiving induction chemotherapy will undergo a baseline integrated [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan before the start of concurrent chemoradiation. This baseline assessment is optional in patients not receiving neo-adjuvant treatment.
All patients will undergo a dedicated FDG PET/CT protocol 12 weeks after the end of chemoradiation (primary endpoint). In PET/CT negative patients, 2 monthly control visits will be performed complemented with additional imaging as required. All patients will undergo PET/CT 1 year after completing chemoradiation unless recurrent/residual disease was already proven pathologically. Patients with a PET/CT suspected for residual nodal disease must have pathological proof of nodal involvement (fine needle aspiration in non-operable patients or neck dissection in the others) before salvage chemotherapy is started.
In a subset of patients receiving induction chemotherapy prior to concurrent chemoradiation, an additional FDG PET/CT scan will be performed at baseline and after 1 cycle of chemotherapy to evaluate the metabolic response to the treatment (secondary endpoint).
- Being tested
- Integrated FDG PET/CT
- Keywords
- Locally advanced, HNSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated FDG PET/CTOther
Optimized PET/CT imaging with dedicated head-and-neck protocol
| Study group | Role | What they receive |
|---|---|---|
| Imaging group | Not described Receives: Other: Integrated FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value (NPV) of FDG PET/CT
The negative predictive value (NPV) of FDG PET/CT for detecting residual nodal involvement
Measured: 12 weeks after chemoradiation
Secondary outcomes (4)
The sensitivity and specificity of high-resolution FDG PET/CT
Measured: 12 weeks after chemoradiation
The sensitivity and specificity of dual time point FDG PET/CT
Measured: 12 weeks after chemoradiation
The number of additional metastases found on PET and the % change in patient management
Measured: Prior to start of chemoradiation
DFS and OS, correlation with baseline SUV, early PET response and with HPV status
Measured: 1 year after completion of chemoradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startFeb 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Squamous Cell Carcinoma of the Head and Neck RegionStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Principal investigator, Tim Van den Wyngaert, University Hospital, Antwerp
- Investigators
- Sigrid Stroobants, MD, PhD, Principal investigator, University Hospital, AntwerpLaurens Carp, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179360
- Sponsor's protocol ID
- IWT-90867
- Acronym
- ECLYPS
- Status last verified
- Nov 2017
- First submitted
- 9 Aug 2010
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Van den Wyngaert T, Helsen N, Carp L, Hakim S, Martens MJ, Hutsebaut I, Debruyne PR, Maes ALM, van Dinther J, Van Laer CG, Hoekstra OS, De Bree R, Meersschout SAE, Lenssen O, Vermorken JB, Van den Weyngaert D, Stroobants S; ECLYPS investigators. Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography After Concurrent Chemoradiotherapy in Locally Advanced Head-and-Neck Squamous Cell Cancer: The ECLYPS Study. J Clin Oncol. 2017 Oct 20;35(30):3458-3464. doi: 10.1200/JCO.2017.73.5845. Epub 2017 Aug 30.
PubMed 28854069Helsen N, Van den Wyngaert T, Carp L, De Bree R, VanderVeken OM, De Geeter F, Maes A, Cambier JP, Spaepen K, Martens M, Hakim S, Beels L, Hoekstra OS, Van den Weyngaert D, Stroobants S; ECLYPS Consortium; Van Laer C, Specenier P, Maes A, Debruyne P, Hutsebaut I, Van Dinter J, Homans F, Goethals L, Lenssen O, Deben K. Quantification of 18F-fluorodeoxyglucose uptake to detect residual nodal disease in locally advanced head and neck squamous cell carcinoma after chemoradiotherapy: results from the ECLYPS study. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1075-1082. doi: 10.1007/s00259-020-04710-4. Epub 2020 Feb 10.
PubMed 32040611
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Combined [18F]Fluoro-2-deoxy-D-glucose (FDG) PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Potentially Operable Locally Advanced Head and Neck Squamous Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT01179360
- Acronym / sponsor ID
- ECLYPS / IWT-90867
- Keywords
- Locally advanced, HNSCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Aug 2010 (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.
To determine if combined [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) is performant enough with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, N2 and N3 head and neck squamous cell carcinoma (HNSCC).
Primary study hypothesis: The lower bound of the 95% confidence interval (CI) of the negative predictive value (NPV) of FDG PET/CT to detect residual malignant lymph node involvement at 12 weeks after completing chemoradiation will exceed 85%.
Detailed description
Patients with locally advanced, N2 and N3 head and neck squamous cell carcinoma (HNSCC) will be recruited. All subjects receiving induction chemotherapy will undergo a baseline integrated [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan before the start of concurrent chemoradiation. This baseline assessment is optional in patients not receiving neo-adjuvant treatment.
All patients will undergo a dedicated FDG PET/CT protocol 12 weeks after the end of chemoradiation (primary endpoint). In PET/CT negative patients, 2 monthly control visits will be performed complemented with additional imaging as required. All patients will undergo PET/CT 1 year after completing chemoradiation unless recurrent/residual disease was already proven pathologically. Patients with a PET/CT suspected for residual nodal disease must have pathological proof of nodal involvement (fine needle aspiration in non-operable patients or neck dissection in the others) before salvage chemotherapy is started.
In a subset of patients receiving induction chemotherapy prior to concurrent chemoradiation, an additional FDG PET/CT scan will be performed at baseline and after 1 cycle of chemotherapy to evaluate the metabolic response to the treatment (secondary endpoint).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging group | – | Other: Integrated FDG PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced, N2 and N3 HNSCC
Key inclusion criteria (2 listed)
- Patients with locoregionally advanced HNSCC (clinically and/or radiological N2 or N3 disease, any T stage) with no evidence of distant metastases, scheduled for concurrent chemoradiation and being potential candidates for a subsequent neck dissection.
- Induction chemotherapy is allowed if this approach is followed by concurrent chemo-radiation.
Key exclusion criteria (4 listed)
- Other head and neck cancer histologies
- Upfront inoperable patients in the neck (eg. carotid invasion)
- Presence of distant metastases
- A history of another primary malignancy, except when disease-free for at least 5 years after radical treatment, or except for treated basaloid skin cancer or in situ carcinoma of the cervix
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 |
|---|---|---|
| Integrated FDG PET/CTOptimized PET/CT imaging with dedicated head-and-neck protocol | Other | Imaging group |
Primary outcome
Negative predictive value (NPV) of FDG PET/CT
Time frame: 12 weeks after chemoradiation
The negative predictive value (NPV) of FDG PET/CT for detecting residual nodal involvement
4 secondary outcomes
The sensitivity and specificity of high-resolution FDG PET/CT
Time frame: 12 weeks after chemoradiation
The sensitivity and specificity of dual time point FDG PET/CT
Time frame: 12 weeks after chemoradiation
The number of additional metastases found on PET and the % change in patient management
Time frame: Prior to start of chemoradiation
DFS and OS, correlation with baseline SUV, early PET response and with HPV status
Time frame: 1 year after completion of chemoradiation
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 17 Nov 2017.
- Results publication: PubMed 28854069Van den Wyngaert T, Helsen N, Carp L, Hakim S, Martens MJ, Hutsebaut I, Debruyne PR, Maes ALM, van Dinther J, Van Laer CG, Hoekstra OS, De Bree R, Meersschout SAE, Lenssen O, Vermorken JB, Van den Weyngaert D, Stroobants S; ECLYPS investigators. Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography After Concurrent Chemoradiotherapy in Locally Advanced Head-and-Neck Squamous Cell Cancer: The ECLYPS Study. J Clin Oncol. 2017 Oct 20;35(30):3458-3464. doi: 10.1200/JCO.2017.73.5845. Epub 2017 Aug 30.
- Derived from this study: PubMed 32040611Helsen N, Van den Wyngaert T, Carp L, De Bree R, VanderVeken OM, De Geeter F, Maes A, Cambier JP, Spaepen K, Martens M, Hakim S, Beels L, Hoekstra OS, Van den Weyngaert D, Stroobants S; ECLYPS Consortium; Van Laer C, Specenier P, Maes A, Debruyne P, Hutsebaut I, Van Dinter J, Homans F, Goethals L, Lenssen O, Deben K. Quantification of 18F-fluorodeoxyglucose uptake to detect residual nodal disease in locally advanced head and neck squamous cell carcinoma after chemoradiotherapy: results from the ECLYPS study. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1075-1082. doi: 10.1007/s00259-020-04710-4. Epub 2020 Feb 10.
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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.
Sigrid Stroobants, MD, PhD principal investigator
University Hospital, Antwerp
Laurens Carp, MD principal investigator
University Hospital, Antwerp
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region, run by University Hospital, Antwerp at 3 sites in 2 countries.
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 2 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Netherlands. 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?
Negative predictive value (NPV) of FDG PET/CT (time frame: 12 weeks after chemoradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179360, which also lists 2 linked publications.
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 17 Nov 2017.