Clinical trial NCT01179360: Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region
Keywords: Locally advanced
HNSCC
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2010-08-11
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced, N2 and N3 HNSCC

Brief 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 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Negative predictive value (NPV) of FDG PET/CT
timeFrame: 12 weeks after chemoradiation
Secondary outcomes:
measure: The sensitivity and specificity of high-resolution FDG PET/CT
timeFrame: 12 weeks after chemoradiation
measure: The sensitivity and specificity of dual time point FDG PET/CT
timeFrame: 12 weeks after chemoradiation
measure: The number of additional metastases found on PET and the % change in patient management
timeFrame: Prior to start of chemoradiation
measure: DFS and OS, correlation with baseline SUV, early PET response and with HPV status
timeFrame: 1 year after completion of chemoradiation
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
city: Turnhout
country: Belgium
facility: AZ Turnhout
state: Antwerp
city: Amsterdam
country: Netherlands
facility: Academisch Ziekenhuis Vrije Universiteit Amsterdam
Study officials:
affiliation: University Hospital, Antwerp
name: Sigrid Stroobants, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Laurens Carp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.