Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT06775756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2025-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Dose and Irradiated Volume in Cervical Prophylactic Irradiation for Nasopharyngeal Cancer
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'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 474}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional failure-free survival', 'timeFrame': '3 years', 'description': 'The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '3 years', 'description': 'time from the date of the start of chemotherapy to death due to any cause'}, {'measure': 'Local failure-free survival (LFFS)', 'timeFrame': '3 years', 'description': 'The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.'}, {'measure': 'Distant metastasis-free survival', 'timeFrame': '3 years', 'description': 'The distant metastasis-free survival rate will be estimated using Kaplan-Meier'}, {'measure': 'Number of participants with adverse events', 'timeFrame': '3 years'}, {'measure': 'Incidence of acute and late toxicity', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether reducing both the dose and the irradiated volume of cervical prophylactic irradiation in patients with nasopharyngeal cancer can maintain efficacy while decreasing toxicity. This will be achieved through a comparison of standard cervical prophylactic irradiation with a reduced-dose and reduced-volume approach.', 'detailedDescription': 'Patients with non-metastatic nasopharyngeal cancer who are candidates for receiving definitive IMRT are randomly assigned to receive either standard cervical prophylactic irradiation or a reduced-dose and reduced-volume approach. The standard arm receives the conventional dose and volume of irradiation, while the experimental arm receives a lower dose and a smaller irradiated volume. Both groups will undergo intensity-modulated radiotherapy (IMRT) to the primary tumor and involved lymph nodes. The primary endpoint of this study is regional-control (RC), and secondary endpoints include overall survival (OS), local control (LC), distant metastasis-free survival (DMFS), and toxicity. All efficacy analyses will be conducted in the intention-to-treat population, and the safety population will include only patients who receive their randomly assigned treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;\n2. No distant metastatic;\n3. Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;\n4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;\n5. Signing informed consent;\n6. Follow up regularly and comply with test requirements.\n\nExclusion Criteria:\n\n1. Disease progression during IMRT;\n2. Previous malignancy or other concomitant malignant diseases;\n3. The evaluation information of tumor efficacy can not be obtained;\n4. Receive blind treatment in other clinical research;\n5. Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);\n6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;\n7. Active systemic infection;\n8. No or limited capacity for civil conduct;\n9. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;\n10. Pregnancy or lactation period;'}, 'identificationModule': {'nctId': 'NCT06775756', 'briefTitle': 'Reducing Dose and Irradiated Volume in Cervical Prophylactic Irradiation for Nasopharyngeal Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'Phase 3, Prospective, Randomized, Open-Label Study on Simultaneously Reducing Both the Dose and the Irradiated Volume of Cervical Prophylactic Irradiation in Nasopharyngeal Cancer', 'orgStudyIdInfo': {'id': 'CerviReduce'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'The experimental arm receives IMRT to the primary tumor and involved lymph nodes, with a reduced dose and volume of cervical prophylactic irradiation.', 'interventionNames': ['Radiation: IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The standard arm receives IMRT to the primary tumor and involved lymph nodes, with conventional cervical prophylactic irradiation according to 2024 CSCO guideline. Prescribing dose for CTVn2 was 56Gy/33Fx.'}], 'interventions': [{'name': 'IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation', 'type': 'RADIATION', 'description': 'For N0 disease, only cover bilateral RPN and level II. For N1 disease, cover ipsilateral involved level plus subsequent level downword, and cover contralateral level RPN and level II. For N2 disease, cover ipsilateral involved level plus subsequent level downword. For N3 disease, cover ipsilateral involved level plus subsequent level downword, and ensuring a 2cm margin below GTVn if GTVn reach or near the sternoclavicular joint. Notably, for unilateral N3, the contralateral neck would only include RPN and level II. Prescribing dose for CTVn2 was 50Gy/33Fx.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shaojun Lin, DR', 'role': 'CONTACT', 'email': 'linshaojun@yeah.net', 'phone': '13860603879'}, {'name': 'Qiaojuan Guo, DR', 'role': 'CONTACT', 'email': 'guoqiaojuan163@.com', 'phone': '15080013157'}], 'overallOfficials': [{'name': 'Shaojun Lin, DR', 'role': 'STUDY_CHAIR', 'affiliation': 'Fujian Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}