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

Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region Clinical Trial

— ECLYPS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179360
• Other study ID #: IWT-90867
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: November 16, 2017
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: November 2017
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region

Intervention

Other:
• Integrated FDG PET/CT
Optimized PET/CT imaging with dedicated head-and-neck protocol

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp
Belgium	AZ Turnhout	Turnhout	Antwerp
Netherlands	Academisch Ziekenhuis Vrije Universiteit Amsterdam	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Agentschap voor Innovatie door Wetenschap en Technologie

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & Publications (1)

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. Fluorodeo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The sensitivity and specificity of high-resolution FDG PET/CT		12 weeks after chemoradiation
Secondary	The sensitivity and specificity of dual time point FDG PET/CT		12 weeks after chemoradiation
Secondary	The number of additional metastases found on PET and the % change in patient management		Prior to start of chemoradiation
Secondary	DFS and OS, correlation with baseline SUV, early PET response and with HPV status		1 year after completion of chemoradiation