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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)

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ClinicalTrials.gov Identifier: NCT01179360
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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%.


Condition or disease Intervention/treatment
Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region Other: Integrated FDG PET/CT

Detailed 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).


Study Design

Study Type : Observational
Actual Enrollment : 152 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Imaging group Other: Integrated FDG PET/CT
Optimized PET/CT imaging with dedicated head-and-neck protocol


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The sensitivity and specificity of high-resolution FDG PET/CT [ Time Frame: 12 weeks after chemoradiation ]
  2. The sensitivity and specificity of dual time point FDG PET/CT [ Time Frame: 12 weeks after chemoradiation ]
  3. The number of additional metastases found on PET and the % change in patient management [ Time Frame: Prior to start of chemoradiation ]
  4. DFS and OS, correlation with baseline SUV, early PET response and with HPV status [ Time Frame: 1 year after completion of chemoradiation ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with locally advanced, N2 and N3 HNSCC
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
AZ Turnhout
Turnhout, Antwerp, Belgium, 2300
Netherlands
Academisch Ziekenhuis Vrije Universiteit Amsterdam
Amsterdam, Netherlands, 1081HV
Sponsors and Collaborators
University Hospital, Antwerp
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Principal Investigator: Sigrid Stroobants, MD, PhD University Hospital, Antwerp
Principal Investigator: Laurens Carp, MD University Hospital, Antwerp
More Information

Publications:
Responsible Party: Tim Van den Wyngaert, Senior consultant, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01179360     History of Changes
Other Study ID Numbers: IWT-90867
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Tim Van den Wyngaert, University Hospital, Antwerp:
Locally advanced
HNSCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site