Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-04 @ 5:04 PM
Study NCT ID:
NCT02303457
Status:
UNKNOWN
Last Update Posted:
2016-01-28
First Post:
2014-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061887', 'term': 'Conversion to Open Surgery'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 402}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2014-11-02', 'studyFirstSubmitQcDate': '2014-11-28', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-free survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'recurrence rate', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CO2 laser surgery', 'open surgery', 'multicenter prospective', 'randomized', 'controlled clinical studies', 'T1N0 squamous cell carcinoma of glottis with anterior commissure involved'], 'conditions': ['Squamous Cell Carcinoma of Glottis']}, 'descriptionModule': {'briefSummary': 'Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T1N0 SCC of glottic carcinoma with anterior commissure involve\n* No nodal metastasis and distant metastasis\n* All patients must have CT/MR and electronic laryngoscope test before surgery and after surgery\n* Expected lifetime\\>1 year\n* Patients and families agreed to participate in the test and sign the informed consent\n* Without cognitive impairment.\n\nExclusion Criteria:\n\n* With severe cardiac insufficiency Liver and kidney function is not complete systemic infection patients\n* Patients with pregnancy and lactation\n* Have surgery contraindications'}, 'identificationModule': {'nctId': 'NCT02303457', 'briefTitle': 'CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Multicenter, Prospective, Randomized and Controlled Clinical Study 0f CO2 Laser and Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved', 'orgStudyIdInfo': {'id': '2014012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CO2 laser surgery', 'description': "CO2 Laser surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved. All patients, under general anesthesia, underwent endoscopic excision of the lesion using a carbon dioxide (CO2) laser (Sharplan 100) coupled with a microscope (Zeiss) set to an output power of between 5 and 12 W in superpulse mode. The lesion's resection was accomplished in a radical fashion, with a free margin of 2 mm. For lesions which involved the anterior commissure, the excision plane always uncovered the cartilage.", 'interventionNames': ['Procedure: CO2 Laser surgery']}, {'type': 'OTHER', 'label': 'Open surgery', 'description': 'Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved.\n\nopen surgery :Frontolateral Vertical Partial Laryngectomy or laryngofissure with cordectomy was accomplished in a radical fashion, with a free margin of 2 mm.', 'interventionNames': ['Procedure: Open Surgery']}], 'interventions': [{'name': 'CO2 Laser surgery', 'type': 'PROCEDURE', 'description': 'Patients were randomly assigned to CO2 laser surgery group and open Surgery group.', 'armGroupLabels': ['CO2 laser surgery']}, {'name': 'Open Surgery', 'type': 'PROCEDURE', 'description': 'Patients were randomly assigned to CO2 laser surgery group and open Surgery group.', 'armGroupLabels': ['Open surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xuekui liu, doctor', 'role': 'CONTACT', 'email': 'liuxk@sysucc.org.cn', 'phone': '(86-20) 8734 3768'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'xuekui liu, doctor', 'role': 'CONTACT', 'email': 'liuxk@sysucc.org.cn', 'phone': '(86-20) 8734 3768'}], 'overallOfficials': [{'name': 'ye cao, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuekui Liu', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Xuekui Liu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}