Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-27 @ 10:09 PM
Study NCT ID:
NCT00135161
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2005-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2005-08-24', 'studyFirstSubmitQcDate': '2005-08-24', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy', 'timeFrame': 'until 3 months after the end of the radiotherapy'}, {'measure': 'Observation of chronic toxicity', 'timeFrame': 'until 3 months after the end of the radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Therapy response (2-4 months after end of radiotherapy)', 'timeFrame': '2-4 months after end of radiotherapy'}, {'measure': 'Local control at 2 years', 'timeFrame': 'at 2 years'}, {'measure': 'Pattern of recurrence', 'timeFrame': 'at 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neoplasms (squamous cell carcinoma of the head and neck region)'], 'conditions': ['Head and Neck Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).', 'detailedDescription': 'The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard radiotherapeutic treatment for these types of cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a proven histological squamous cell carcinoma of the larynx (only T3-4 NO or Tany N+), hypopharynx, oropharynx\n* Patients who did not undergo surgery for the primary tumor location\n* Patients with a Karnofsky performance score of 70% or more\n* Written informed consent for participation in this trial\n\nExclusion Criteria:\n\n* Other malignancy except for non-melanoma skin cancer\n* Prior irradiation to the head and neck region'}, 'identificationModule': {'nctId': 'NCT00135161', 'briefTitle': 'Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer', 'orgStudyIdInfo': {'id': '2003/202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensity modulated radiation therapy (IMRT).', 'interventionNames': ['Procedure: FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).']}], 'interventions': [{'name': 'FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).', 'type': 'PROCEDURE', 'description': 'FDG-PET-based dose escalation using intensity modulated radiation therapy (IMRT).', 'armGroupLabels': ['Intensity modulated radiation therapy (IMRT).']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Wilfried De Neve, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Belgian Federation Against Cancer', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}