Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2026-03-21 @ 12:06 AM
Study NCT ID:
NCT03008694
Status:
UNKNOWN
Last Update Posted:
2017-01-02
First Post:
2016-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}], 'ancestors': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-29', 'studyFirstSubmitDate': '2016-12-23', 'studyFirstSubmitQcDate': '2016-12-29', 'lastUpdatePostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progress free survival', 'timeFrame': 'baseline to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PET/CT'], 'conditions': ['Oral Cancer', 'Radiotherapy; Complications']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol', 'detailedDescription': 'Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed oral squamous-cell carcinoma\n* Age \\> 17 years\n* Signed informed consent\n* ECOG Performance status 0-2\n* Must be able to start RT within 4 weeks after PET/CT simulation\n\nExclusion Criteria:\n\n* stage IV disease diagnosed before acquisition of staging PET/CT\n* prior radiotherapy to oral and neck\n* Unable to understand study participation\n* Claustrophobia\n* pregnant or breast feeding mothers'}, 'identificationModule': {'nctId': 'NCT03008694', 'briefTitle': 'Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zhongnan Hospital'}, 'officialTitle': 'Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral', 'orgStudyIdInfo': {'id': 'ZhongnanH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'PET/CT', 'interventionNames': ['Device: PET/CT']}], 'interventions': [{'name': 'PET/CT', 'type': 'DEVICE', 'description': 'pet/ct is used as radiotherapy simulation', 'armGroupLabels': ['1']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director,oncology , Principal Investigator, Clinical Professor', 'investigatorFullName': 'yahua zhong', 'investigatorAffiliation': 'Zhongnan Hospital'}}}}