Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-04 @ 7:03 PM
Study NCT ID:
NCT07376603
Status:
RECRUITING
Last Update Posted:
2026-01-29
First Post:
2026-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 169}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-26', 'studyFirstSubmitDate': '2026-01-17', 'studyFirstSubmitQcDate': '2026-01-26', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-Free Survival', 'timeFrame': '3-year', 'description': 'Time from diagnosis to the disease relapse (either locoregional recurrence or distant metastasis) or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Locoregional Relapse-Free Survival', 'timeFrame': '3-year', 'description': 'Time from diagnosis to first documented locoregional recurrence before the last follow-up visit.'}, {'measure': 'Distant Metastasis-Free Survival', 'timeFrame': '3-year', 'description': 'Time from diagnosis to first documented distant metastasis before the last follow-up visit'}, {'measure': 'Overall Survival', 'timeFrame': '3-year', 'description': 'Time from diagnosis to death from any cause or to the last follow-up visit for patients still alive.'}, {'measure': 'Safety of Radiation', 'timeFrame': 'at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months', 'description': 'Acute and late radiation toxicities were graded with the CTCAE criteria'}, {'measure': 'Quality of life (EORTC QLQ C30)', 'timeFrame': 'at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.', 'description': 'Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30), the range is 0-100, higher scores mean a worse outcome.'}, {'measure': 'Quality of life score QLQ-HN35', 'timeFrame': 'at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.', 'description': 'The quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35; the range is 0-100, with higher scores indicating a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Cancinomar', 'Stage IB', 'RT along'], 'conditions': ['Nasopharyngeal Cancinoma (NPC)', 'Intensity-modulated Radiotherapy', 'Stage IB']}, 'descriptionModule': {'briefSummary': 'This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stage IB NPC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Histopathologically confirmed, newly diagnosed nasopharyngeal carcinoma 3. Age 18-70 years 4. Stage IB disease (T1-2N1M0) per the 9th edition AJCC/UICC staging system 5. Upper-neck nodal metastasis only: inferior border of every positive node at or above the inferior border of the hyoid bone 6. ECOG performance status 0-2 7. Adequate bone-marrow function\n\nExclusion Criteria:\n\n1. Age \\> 70 years or \\< 18 years\n2. Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass\n3. Largest metastatic lymph-node ≥ 3 cm in the longest dimension\n4. Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone\n5. Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix\n6. Pregnancy or lactation (serum pregnancy test required for women of child-bearing potential; effective contraception mandatory during treatment)\n7. Previous radiotherapy to the head-and-neck region\n8. Prior chemotherapy or surgery for the primary tumour or metastatic nodes (diagnostic procedures excluded)\n9. Any severe comorbidity that would confer unacceptable risk or compromise protocol adherence, including but not limited to unstable cardiac disease, renal failure, chronic hepatitis, or uncontrolled psychiatric disorder\n10. History of severe hypersensitivity reactions'}, 'identificationModule': {'nctId': 'NCT07376603', 'briefTitle': 'IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features', 'orgStudyIdInfo': {'id': 'NPC0013.1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IMRT along', 'description': 'IMRT Alone for 169 Patients with Stage IB Nasopharyngeal Carcinoma Without High-Risk Features', 'interventionNames': ['Radiation: IMRT along']}], 'interventions': [{'name': 'IMRT along', 'type': 'RADIATION', 'description': 'All patients administered with definitive radiotherapy', 'armGroupLabels': ['IMRT along']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiaojuan Guo, Professor', 'role': 'CONTACT', 'email': 'guoqiaojuan@163.com', 'phone': '+8615080013157'}], 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Qiaojuan Guo, Professor', 'role': 'CONTACT', 'email': 'fjzlec@163.com', 'phone': '+8615080013157'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qiaojuan Guo', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qiaojuan Guo', 'investigatorAffiliation': 'Fujian Cancer Hospital'}}}}