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.
18 Years
N/A
Both
Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region
Trial Information
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.
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).
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Negative predictive value (NPV) of FDG PET/CT
Outcome Description:
The negative predictive value (NPV) of FDG PET/CT for detecting residual nodal involvement
Outcome Time Frame:
12 weeks after chemoradiation
Safety Issue:
No
Principal Investigator
Sigrid Stroobants, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Antwerp
Authority:
Belgium: Ethics Committee
Study ID:
IWT-90867
NCT ID:
NCT01179360
Start Date:
February 2011
Completion Date:
December 2013
Related Keywords:
- Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region
- Locally advanced
- HNSCC
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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