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
  Purpose

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.


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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 173
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Imaging group Other: Integrated FDG PET/CT
Optimized PET/CT imaging with dedicated head-and-neck protocol

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179360

Contacts
Contact: Sigrid Stroobants, MD, PhD +3238213568 nucleairegeneeskunde@uza.be

Locations
Belgium
Antwerp University Hospital Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Sigrid Stroobants, MD, PhD    +3238213568    nucleairegeneeskunde@uza.be   
AZ Turnhout Recruiting
Turnhout, Antwerp, Belgium, 2300
Contact: Michel Martens, MD    +3214406902      
Netherlands
Academisch Ziekenhuis Vrije Universiteit Amsterdam Recruiting
Amsterdam, Netherlands, 1081HV
Contact: Remco de Bree, MD, PhD    +31204441140      
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

No publications provided

Responsible Party: prof. dr. S. Stroobants, Nuclear Medicine - Antwerp University Hospital
ClinicalTrials.gov Identifier: NCT01179360     History of Changes
Other Study ID Numbers: IWT-90867
Study First Received: August 9, 2010
Last Updated: February 2, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on August 20, 2014