Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) (ECLYPS)
Recruitment status was Recruiting
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: FDG PET/CT will have a negative predictive value (NPV) higher than 90% to detect residual malignant lymph node involvement at 12 weeks after completing chemoradiation.
Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region
Other: Integrated FDG PET/CT
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- Negative predictive value (NPV) of FDG PET/CT [ Time Frame: 12 weeks after chemoradiation ] [ Designated as safety issue: No ]The negative predictive value (NPV) of FDG PET/CT for detecting residual nodal involvement
- The sensitivity and specificity of high-resolution FDG PET/CT [ Time Frame: 12 weeks after chemoradiation ] [ Designated as safety issue: No ]
- The sensitivity and specificity of dual time point FDG PET/CT [ Time Frame: 12 weeks after chemoradiation ] [ Designated as safety issue: No ]
- The number of additional metastases found on PET and the % change in patient management [ Time Frame: Prior to start of chemoradiation ] [ Designated as safety issue: No ]
- DFS and OS, correlation with baseline SUV, early PET response and with HPV status [ Time Frame: 1 year after completion of chemoradiation ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Other: Integrated FDG PET/CT
Optimized PET/CT imaging with dedicated head-and-neck protocol
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179360
|Contact: Sigrid Stroobants, MD, PhDfirstname.lastname@example.org|
|Antwerp University Hospital||Recruiting|
|Edegem, Antwerp, Belgium, 2650|
|Contact: Sigrid Stroobants, MD, PhD +3238213568 email@example.com|
|Turnhout, Antwerp, Belgium, 2300|
|Contact: Michel Martens, MD +3214406902|
|Academisch Ziekenhuis Vrije Universiteit Amsterdam||Recruiting|
|Amsterdam, Netherlands, 1081HV|
|Contact: Remco de Bree, MD, PhD +31204441140|
|Principal Investigator:||Sigrid Stroobants, MD, PhD||University Hospital, Antwerp|
|Principal Investigator:||Laurens Carp, MD||University Hospital, Antwerp|