Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-25 @ 10:34 PM
Study NCT ID:
NCT03689556
Status:
UNKNOWN
Last Update Posted:
2020-04-06
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examine the Prognostic Role of FLT PET/CT for Patients With LR-NPC Treated by Carbon Ion Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity', 'timeFrame': 'The reduction of FLT uptake will be calculated over two time points, at the baseline and at the time point that CIRT is completed.', 'description': 'The sensitivity and specificity of FLT uptake reduction in predicting the treatment response evaluated by MRI scan at 3 months after completion of CIRT.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Duration from the date the diagnosis of LR-NPC is made until date of patient death or the last follow-up, whichever comes first, assessed up to 36 months', 'description': '3-year overall survival'}, {'measure': 'Local progression-free survival (LPFS)', 'timeFrame': 'Duration from the date the diagnosis of LR-NPC is made until date of documented local failure or the last follow-up/patient death, whichever comes first, assessed up to 36 months', 'description': '3-year local progression-free survival'}, {'measure': 'Regional progression-free survival (RPFS)', 'timeFrame': 'Duration from the date the diagnosis of LR-NPC is made until date of documented regional failure or the last follow-up/patient death, whichever comes first, assessed up to 36 months', 'description': '3-year regional progression-free survival'}, {'measure': 'Distant metastasis-free survival (DMFS)', 'timeFrame': 'Duration from the date the diagnosis of LR-NPC is made until date of documented distant metastasis or the last follow-up/patient death, whichever comes first, assessed up to 36 months', 'description': '3-year distant metastasis-free survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FLT PET/CT', 'carbon ion radiation therapy', 're-irradiation'], 'conditions': ['Recurrent Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'We aim, in this study, to examine whether reduction of FLT PET derived SUV before and after carbon ion radiotherapy can predict the treatment response and survivals for patients with locoregionally recurrent nasopharyngeal carcinoma.', 'detailedDescription': 'This is a single-arm phase II clinical trial evaluating the prognostic value of FLT PET/CT for patients with locoregionally recurrent nasopharyngeal carcinoma. All patients will receive FLT PET/CT scans before and after carbon ion radiotherapy (CIRT). The sensitivity and specificity of reduction of FLT uptake reduction in terms of predicting the treatment outcome evaluated by MRI at 3 months after completion of CIRT according to RECIST 1.1. Its predictive value of OS, LPFS, RPFS and DMFS will be examined as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive LR-NPC patients treated at SPHIC will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed as primary nasopharyngeal carcinoma;\n* With recurrence at nasopharynx and/or recurrent retropharyngeal lymph node, recurrence was diagnosed by imaging or pathology studies;\n* Already received one course of definitive radiation therapy, at least 6 months ago;\n* Able to receive contrast MRI scan and PET/CT scan;\n* ECOG: 0-2;\n* Anticipated survival time \\>= 12 months;\n* With sufficient major organ functions;\n* Willing to sign informed consent.\n\nExclusion Criteria:\n\n* Metal implants that might significantly influence the radiation dose distribution;\n* Dose constrains for organs-at-risk are beyond acceptable limit;\n* With comorbidities/conditions that might influence the effectiveness of carbon-ion therapy;\n* Pregnant or within lactation period;\n* Drug/alcohol addiction;\n* With mental disorder that might impede the completion of therapy.'}, 'identificationModule': {'nctId': 'NCT03689556', 'briefTitle': 'Examine the Prognostic Role of FLT PET/CT for Patients With LR-NPC Treated by Carbon Ion Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Proton and Heavy Ion Center'}, 'officialTitle': 'A Phase II Clinical Trial Evaluating the Role of FLT PET/CT in Predicting Treatment Response of Carbon-ion Radiotherapy for Patients With Locoregionally Recurrent Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'SPHIC-TR-HNCNS-2018-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FLT PET/CT', 'description': 'Patients with locoregionally recurrent nasopharyngeal carcinoma (LR-NPC) will receive FLT PET/CT scans before CIRT and after completion of CIRT.', 'interventionNames': ['Diagnostic Test: FLT PET/CT']}], 'interventions': [{'name': 'FLT PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': "Patients will receive 3'-deoxy-3'-\\[18F\\]fluorothymidine (FLT) PET/CT scans before CIRT and after completion of CIRT.", 'armGroupLabels': ['FLT PET/CT']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lin Kong, MD', 'role': 'CONTACT', 'email': 'lin.kong@sphic.org.cn', 'phone': '+86-21-38296666'}, {'name': 'Jiyi Hu, MD', 'role': 'CONTACT', 'email': 'jiyi.hu@sphic.org.cn'}], 'overallOfficials': [{'name': 'Jiade J Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Proton and Heavy Ion Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jiade J. Lu', 'investigatorAffiliation': 'Shanghai Proton and Heavy Ion Center'}}}}