Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-02 @ 6:50 AM
Study NCT ID:
NCT00528294
Status:
TERMINATED
Last Update Posted:
2022-12-20
First Post:
2007-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'whyStopped': 'Study status unknown Investigator retired and no longer working in the institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2007-09-11', 'studyFirstSubmitQcDate': '2007-09-11', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose.', 'timeFrame': '3 months after end of treatment'}, {'measure': 'Superior local control with Grid 18F-FDG-PET BG-IMRT using previously obtained maximum tolerated dose.', 'timeFrame': '1 year.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Recurrent head and neck tumors'], 'conditions': ['Head and Neck Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'This trials examines the feasibility of GRID-therapy combined with biologically imaging based IMRT (BG-IMRT). Within this trial, the strict toxicity parameters of primary treatment of head and neck tumors are used. The GRID and BG-IMRT technique might be possible to reduce the total radiation dose 2 to 3 times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent or new head or neck tumor\n* 18 years or older'}, 'identificationModule': {'nctId': 'NCT00528294', 'briefTitle': 'Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area', 'orgStudyIdInfo': {'id': '2007/010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'GRID-radiotherapy followed by biological imaging guided IMRT', 'interventionNames': ['Radiation: GRID radiotherapy']}], 'interventions': [{'name': 'GRID radiotherapy', 'type': 'RADIATION', 'description': 'GRID-radiotherapy followed by biological imaging guided IMRT', 'armGroupLabels': ['1']}]}, '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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}