Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region Clinical Trial
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%.
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).
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