Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT03025958
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2017-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C501466', 'term': 'nimotuzumab'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response (CR) rate at 1 month after radiotherapy', 'timeFrame': '1 month after radiotherapy', 'description': 'CR was defined as a complete lack of unequivocal soft tissue mass in the primary site and cervical lymph nodes with a short axis of less than 10 mm assessed by fiber-optic nasopharyngoscopy and MRI of the head and neck according to the Response Evaluation Criteria in Solid Tumors V.1.1 (RECIST V.1.1).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma', 'detailedDescription': 'Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma\n\nExclusion Criteria:\n\n* A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions, supposed to live less than 6 months.'}, 'identificationModule': {'nctId': 'NCT03025958', 'briefTitle': 'Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Concurrent Nimotuzumab and Intensity-modulated Radiotherapy for Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'ZJCH-2016-HN04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nimotuzumab', 'description': 'Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).', 'interventionNames': ['Drug: Nimotuzumab', 'Radiation: Radiation']}], 'interventions': [{'name': 'Nimotuzumab', 'type': 'DRUG', 'otherNames': ['humanized anti-epidermal factor receptor monoclonal antibody h-R3'], 'description': 'Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.', 'armGroupLabels': ['Nimotuzumab']}, {'name': 'Radiation', 'type': 'RADIATION', 'description': 'Briefly, the dose prescribed was 70.4 Gy, 70.4 Gy, 60.8 Gy, and 54.4 Gy in 32 fractions delivered over 6 weeks at the periphery of the planning target volume (PTV)nx+rn, PTVnd, PTV1, and PTV2, respectively, using the simultaneous integrated boost technique.', 'armGroupLabels': ['Nimotuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Xiaozhong Chen', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Xiaozhong Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of department', 'investigatorFullName': 'Chen Xiaozhong', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}