Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 2:02 PM
Study NCT ID:
NCT05741008
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2023-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2023-02-11', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of acute mucosal ulcers with a toxicity grade 3 or above', 'timeFrame': 'up to 6 months', 'description': 'incidence of acute mucosal ulcers (including those in the oral cavity and pharyngeal wall mucosa) with a toxicity grade 3 or above within 6 months after radiotherapy (that is, between the initiation of radiotherapy to 3 months postradiotherapy) among patients with no recurrence in the reduced-target area'}], 'secondaryOutcomes': [{'measure': 'locoregional recurrence-free survival', 'timeFrame': 'up to 1 year', 'description': 'which was defined as the time from enrollment to the occurrence of locoregional recurrence, with the last tumor assessment date serving as the censoring time in the absence of locoregional recurrence'}, {'measure': 'Distant metastasis-free survival', 'timeFrame': 'up to 1 years', 'description': 'The time from date of treatment until date of death due to any cause, assessed up to 1 years.'}, {'measure': 'Overall survival', 'timeFrame': 'up to 1 years', 'description': 'The time from date of treatment until date of death due to any cause, assessed up to 1 years.'}, {'measure': 'Progress Free Survival', 'timeFrame': 'up to 1 years', 'description': 'The time from date of treatment until date of death due to any cause, assessed up to 1 years.'}, {'measure': 'Acute radiation toxicity', 'timeFrame': 'up to 3 months', 'description': 'The injuries after the beginning of radiotherapy include skin, mucosa, pharynx and esophagus, eyes, ears, nervous system, blood system and other organs and tissues，assessed up to 3 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reduced target', 'Nasopharyngeal Carcinoma', 'Radiotherapy'], 'conditions': ['Toxicity Due to Radiotherapy', 'Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'To determine whether subtractive radiotherapy can significantly reduce the acute side effects of radiotherapy and improve the quality of life of patients on the basis of ensuring the existing curative effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histopathologically confirmed nasopharyngeal nonkeratologic carcinoma (differentiated or undifferentiated, i.e., WHO type II or Type III).\n2. The clinical stage is TanyN2-3M0, III-IVa (AJCC 8th edition stage).\n3. Patients who have not received radiation therapy before.\n4. After induction chemotherapy, CR or PR were evaluated by radiography.\n5. Age 18-65 years old.\n6. ECOG score of 0-1.\n7. Good organ function\n8. The patient has signed an informed letter and is willing and able to comply with the planned visits, treatment plans, laboratory tests and other research programs.\n\nExclusion Criteria:\n\n1. Patients with keratinizing squamous cell carcinoma account for only about 5% of the total pathological types, and the sensitivity of radiotherapy is poor compared with the other two types heterogeneous, so nasopharyngeal carcinoma with pathology of keratinizing squamous cells (WHO type I) is excluded.\n2. Patients with relapsed and distant metastases.\n3. The metastatic lymph nodes are located in the target area (Ib zone, the lateral group of the retropharyngeal lymphatic drainage area (VII), and the cervical lymphatic rainage area The medial border moves from top to bottom from the medial border of the common carotid artery to the lateral border, from the annular cartilage to the superior sternal border, sternoclavicular.The triangular area between the anterior and posterior edges of the medial mastoid muscle and the anterior and lateral border of the jugular arteriovenous sheath and lateral border of the thyroid glanddomain).\n4. Nasopharyngeal primary tumor or retropharyngeal metastatic lymph node invasion of oropharynx.\n5. Severe heart disease, lung dysfunction, heart function, lung function lower than grade 3 (including grade 3).\n6. Those whose laboratory test values do not meet the relevant criteria within 7 days before enrollment.\n7. Those who have participated in clinical trials of other drugs within 3 months before treatment.\n8. Pregnant or lactating women.\n9. Patients assessed by investigators to be unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.'}, 'identificationModule': {'nctId': 'NCT05741008', 'briefTitle': 'Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Kunming Medical University'}, 'officialTitle': 'Clincal Study of Reduced Target Radiotherapy Based on The Law and Distribution Characteristics of Cervical Lymph Nodes Metastasis in Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': '2021BS005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced target radiotherapy', 'description': 'According to our institutional guidelines, GTVnx included the primary tumor volume and the enlarged retropharyngeal nodes, while GTVnd was the volume of involved gross cervical lymph nodes.\n\nThe clinical tumor volume (CTV) includes the primary tumor with potential subclinical disease. The high-risk clinical target volume (CTV1) was defined as the GTVnx plus a 5-mm margin to encompass the high-risk sites of microscopic extension, the whole nasopharynx, retropharyngeal nodal regions and . The low-risk clinical target volume (CTV2) was defined as the whole neck area.(Ib, VIIb, and the commom carotid artery are not included).', 'interventionNames': ['Radiation: Target range']}], 'interventions': [{'name': 'Target range', 'type': 'RADIATION', 'description': 'Compared with conventional radiotherapy, the target dose is unchanged and the CTV2 volume is reduced.', 'armGroupLabels': ['Reduced target radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650032', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'First Affiliated Hospital of Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Kunming Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,Phd', 'investigatorFullName': 'Zhiqiang, Wang', 'investigatorAffiliation': 'First Affiliated Hospital of Kunming Medical University'}}}}