Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-12 @ 12:53 AM
Study NCT ID:
NCT03358602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2017-12-12
First Post:
2017-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-10', 'studyFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2017-11-26', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck control rates', 'timeFrame': '2 years', 'description': 'The percentage of patients without cervical lymph node metastasis'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '1 year', 'description': 'The proportion of patients did not find clear evidence of recurrence or metastasis'}, {'measure': 'Disease-free survival', 'timeFrame': '2 years', 'description': 'The proportion of patients did not find clear evidence of recurrence or metastasis'}, {'measure': 'Disease-free survival', 'timeFrame': '3 years', 'description': 'The proportion of patients did not find clear evidence of recurrence or metastasis'}, {'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'The proportion of patients did not find clear evidence of recurrence or metastasis'}, {'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'The proportion of patients who survived'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'The proportion of patients who survived'}, {'measure': 'Quality of life (EORTC QLQ-C30)', 'timeFrame': '1 year', 'description': 'Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30'}, {'measure': 'Quality of life (EORTC QLQ-HN35)', 'timeFrame': '1 year', 'description': 'Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35'}, {'measure': 'Treatment cost', 'timeFrame': '4 weeks', 'description': 'The total cost of the treatment of the primary and cervical lymph nodes until the discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Supraglottic cancer', 'Laryngeal cancer', 'Cervical lymph node', 'Neck dissection'], 'conditions': ['Supraglottic Cancer']}, 'descriptionModule': {'briefSummary': 'Supraglottic cancer is a main type of laryngeal carcinoma, which is one of the most common head and neck tumors. Cervical nodal metastasis is an important prognostic factor in supraglottic cancer. Current management, following the US National Comprehensive Cancer Network guidelines for T1-2, N0 supraglottic cancer (NCCN 2017), is either definitive radiotherapy or primary surgery with or without neck dissection. The optimal neck treatments strategy remains unclear in clinical settings owing to the limitation of a small number of retrospective studies and a lack of prospective trials. The investigators conducted a prospective, randomised trial to compare radiotherapy with neck dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document\n2. Age≥ 18 and≤ 75 years\n3. Histological/ cytological/ Imaging examination proven supraglottic squamous-cell carcinoma in preoperative assessment\n4. Cervical node negative according to the imaging characteristics and the physical examination\n5. KPS≥ 70\n6. Normal bone marrow reserve function and normal liver, kidney function\n7. Expected survival period≥ 12 months\n\nExclusion Criteria:\n\n1. Inability to provide an informed consent\n2. Proved distant metastasis\n3. Clinical stage 3-4\n4. The patient has received prior surgery or radiotherapy (except for biopsy )\n5. The patient has received chemotherapy(including targeted therapies) or immunotherapy\n6. Prior malignancy within the previous 5 years\n7. Severe mental disorders\n8. Pregnant or lactating women\n9. Other disease requiring simultaneous surgery or radiotherapy\n10. Researchers believe that the situation is unsuitable for participation in the group'}, 'identificationModule': {'nctId': 'NCT03358602', 'briefTitle': 'Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'TJLC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy', 'description': 'Radiotherapy \\& open partial supraglottic laryngectomy(primary tumor)', 'interventionNames': ['Radiation: Radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Elective neck dissection', 'description': 'Elective neck dissection \\& open partial supraglottic laryngectomy(primary tumor)', 'interventionNames': ['Procedure: Selective neck dissection']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes', 'armGroupLabels': ['Radiotherapy']}, {'name': 'Selective neck dissection', 'type': 'PROCEDURE', 'description': 'Selective neck dissection, defined as surgical clearance of the upper jugular (leveI II), midjugular (level III) and sometimes submandibular (level I) nodes, is used to manage the cervical lymph nodes', 'armGroupLabels': ['Elective neck dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Dong Xu Wang, Ph.D', 'role': 'CONTACT', 'email': 'wxd.1133@163.com', 'phone': '+86 022 23340123'}, {'name': 'Ze Zhang, MD', 'role': 'CONTACT', 'email': 'zhangze_smu@163.com', 'phone': '+86 022 23340123'}, {'name': 'Lun Zhang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University Cancer Institute and Hopital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Dong Xu Wang, Ph.D', 'role': 'CONTACT', 'email': 'wxd.1133@163.com', 'phone': '+86 022 23340123'}, {'name': 'Ze Zhang, MD', 'role': 'CONTACT', 'email': 'zhangze_smu@163.com', 'phone': '+86 022 23340123'}], 'overallOfficials': [{'name': 'Lun Zhang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': 'Tianjin Medical University Second Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}