Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) (ECLYPS)
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|ClinicalTrials.gov Identifier: NCT01179360|
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : November 17, 2017
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%.
|Condition or disease||Intervention/treatment|
|Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region||Other: Integrated FDG PET/CT|
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).
|Study Type :||Observational|
|Actual Enrollment :||152 participants|
|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 Start Date :||February 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Other: Integrated FDG PET/CT
Optimized PET/CT imaging with dedicated head-and-neck protocol
- Negative predictive value (NPV) of FDG PET/CT [ Time Frame: 12 weeks after chemoradiation ]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 ]
- The sensitivity and specificity of dual time point FDG PET/CT [ Time Frame: 12 weeks after chemoradiation ]
- The number of additional metastases found on PET and the % change in patient management [ Time Frame: Prior to start of chemoradiation ]
- DFS and OS, correlation with baseline SUV, early PET response and with HPV status [ Time Frame: 1 year after completion of chemoradiation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179360
|Antwerp University Hospital|
|Edegem, Antwerp, Belgium, 2650|
|Turnhout, Antwerp, Belgium, 2300|
|Academisch Ziekenhuis Vrije Universiteit Amsterdam|
|Amsterdam, Netherlands, 1081HV|
|Principal Investigator:||Sigrid Stroobants, MD, PhD||University Hospital, Antwerp|
|Principal Investigator:||Laurens Carp, MD||University Hospital, Antwerp|