Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT01179360
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2010-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2010-08-09', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative predictive value (NPV) of FDG PET/CT', 'timeFrame': '12 weeks after chemoradiation', 'description': 'The negative predictive value (NPV) of FDG PET/CT for detecting residual nodal involvement'}], 'secondaryOutcomes': [{'measure': 'The sensitivity and specificity of high-resolution FDG PET/CT', 'timeFrame': '12 weeks after chemoradiation'}, {'measure': 'The sensitivity and specificity of dual time point FDG PET/CT', 'timeFrame': '12 weeks after chemoradiation'}, {'measure': 'The number of additional metastases found on PET and the % change in patient management', 'timeFrame': 'Prior to start of chemoradiation'}, {'measure': 'DFS and OS, correlation with baseline SUV, early PET response and with HPV status', 'timeFrame': '1 year after completion of chemoradiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Locally advanced', 'HNSCC'], 'conditions': ['Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region']}, 'referencesModule': {'references': [{'pmid': '28854069', 'type': 'RESULT', 'citation': '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': '32040611', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nPrimary 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%.', 'detailedDescription': '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.\n\nAll 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.\n\nIn 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with locally advanced, N2 and N3 HNSCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Induction chemotherapy is allowed if this approach is followed by concurrent chemo-radiation.\n\nExclusion Criteria:\n\n* Other head and neck cancer histologies\n* Upfront inoperable patients in the neck (eg. carotid invasion)\n* Presence of distant metastases\n* 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'}, 'identificationModule': {'nctId': 'NCT01179360', 'acronym': 'ECLYPS', 'briefTitle': 'Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'IWT-90867'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Imaging group', 'interventionNames': ['Other: Integrated FDG PET/CT']}], 'interventions': [{'name': 'Integrated FDG PET/CT', 'type': 'OTHER', 'description': 'Optimized PET/CT imaging with dedicated head-and-neck protocol', 'armGroupLabels': ['Imaging group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '2300', 'city': 'Turnhout', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'AZ Turnhout', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}, {'zip': '1081HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Vrije Universiteit Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Sigrid Stroobants, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}, {'name': 'Laurens Carp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agentschap voor Innovatie door Wetenschap en Technologie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant', 'investigatorFullName': 'Tim Van den Wyngaert', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}