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

NCT01179360 | Completed

• 1 other identifier: IWT-90867
• Study Type: observational
• Target: 152
• Locations: 2 countries
• Sites: 3

Brief Summary

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%.

Conditions

Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region

Keywords

Locally advanced; HNSCC

Outcome Measures

Primary Outcomes (1)

• Negative predictive value (NPV) of FDG PET/CT

  The negative predictive value (NPV) of FDG PET/CT for detecting residual nodal involvement

  12 weeks after chemoradiation

Secondary Outcomes (4)

• The sensitivity and specificity of high-resolution FDG PET/CT

  12 weeks after chemoradiation

• The sensitivity and specificity of dual time point FDG PET/CT

  12 weeks after chemoradiation

• The number of additional metastases found on PET and the % change in patient management

  Prior to start of chemoradiation

• DFS and OS, correlation with baseline SUV, early PET response and with HPV status

  1 year after completion of chemoradiation

Study Arms (1)

Imaging group

Other: Integrated FDG PET/CT

Interventions

Integrated FDG PET/CT OTHER

Optimized PET/CT imaging with dedicated head-and-neck protocol

Imaging group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced, N2 and N3 HNSCC

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

Study Sites (3)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

AZ Turnhout

Turnhout, Antwerp, 2300, Belgium

Location

Academisch Ziekenhuis Vrije Universiteit Amsterdam

Amsterdam, 1081HV, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 28854069 RESULT

• Helsen N, Van den Wyngaert T, Carp L, De Bree R, VanderVeken OM, De Geeter F, Maes A, Cambier JP, Spaepen K, Martens M, Hakim S, Beels L, Hoekstra OS, Van den Weyngaert D, Stroobants S; ECLYPS Consortium; Van Laer C, Specenier P, Maes A, Debruyne P, Hutsebaut I, Van Dinter J, Homans F, Goethals L, Lenssen O, Deben K. Quantification of 18F-fluorodeoxyglucose uptake to detect residual nodal disease in locally advanced head and neck squamous cell carcinoma after chemoradiotherapy: results from the ECLYPS study. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1075-1082. doi: 10.1007/s00259-020-04710-4. Epub 2020 Feb 10.

  PMID: 32040611 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Sigrid Stroobants, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

• Laurens Carp, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 11, 2010
• Study Start: February 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

BE (2); NL (1)