Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT ID: NCT01179360
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
152 participants
OBSERVATIONAL
2011-02-28
2015-12-31
Brief Summary
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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
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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).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Imaging group
Integrated FDG PET/CT
Optimized PET/CT imaging with dedicated head-and-neck protocol
Interventions
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Integrated FDG PET/CT
Optimized PET/CT imaging with dedicated head-and-neck protocol
Eligibility Criteria
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Inclusion Criteria
* Induction chemotherapy is allowed if this approach is followed by concurrent chemo-radiation.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Agentschap voor Innovatie door Wetenschap en Technologie
OTHER
Responsible Party
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Tim Van den Wyngaert
Senior consultant
Principal Investigators
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Sigrid Stroobants, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Laurens Carp, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
AZ Turnhout
Turnhout, Antwerp, Belgium
Academisch Ziekenhuis Vrije Universiteit Amsterdam
Amsterdam, , Netherlands
Countries
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References
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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.
Helsen 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.
Other Identifiers
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IWT-90867
Identifier Type: -
Identifier Source: org_study_id