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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University Hospital, Antwerp.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01179360
First received: August 9, 2010
Last updated: February 2, 2011
Last verified: February 2011

August 9, 2010
February 2, 2011
February 2011
September 2013   (final data collection date for primary outcome measure)
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
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 ] [ 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 ]
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: 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.

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
173
December 2013
September 2013   (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
Both
18 Years and older
No
Contact: Sigrid Stroobants, MD, PhD +3238213568 nucleairegeneeskunde@uza.be
Belgium,   Netherlands
 
NCT01179360
IWT-90867
No
prof. dr. S. Stroobants, Nuclear Medicine - Antwerp University Hospital
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
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP