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Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) (ECLYPS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179360
First Posted: August 11, 2010
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
Tim Van den Wyngaert, University Hospital, Antwerp
August 9, 2010
August 11, 2010
November 17, 2017
February 2011
December 2015   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01179360 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with locally advanced, N2 and N3 HNSCC
Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region
Other: Integrated FDG PET/CT
Optimized PET/CT imaging with dedicated head-and-neck protocol
Imaging group
Intervention: Other: Integrated FDG PET/CT
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
 
 
NCT01179360
IWT-90867
No
Not Provided
Not Provided
Tim Van den Wyngaert, University Hospital, Antwerp
University Hospital, Antwerp
Agentschap voor Innovatie door Wetenschap en Technologie
Principal Investigator: Sigrid Stroobants, MD, PhD University Hospital, Antwerp
Principal Investigator: Laurens Carp, MD University Hospital, Antwerp
University Hospital, Antwerp
November 2017