Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-29 @ 5:22 PM
Study NCT ID:
NCT03915132
Status:
UNKNOWN
Last Update Posted:
2021-01-29
First Post:
2019-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nimotuzumab Combined With VMAT in Elderly Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2019-03-31', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate', 'timeFrame': '4 months', 'description': 'Complete remission rate will be measured by RECIST 1.1'}], 'secondaryOutcomes': [{'measure': 'acute treatment toxicity', 'timeFrame': 'up to 16 weeks', 'description': 'Acute toxicity will be measured by CTCAE4.0'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '2 years', 'description': 'EORTC,QLQ-C30 Version 3.0 are used.'}, {'measure': 'local control rate', 'timeFrame': '2 years'}, {'measure': 'regional control rate', 'timeFrame': '2 years'}, {'measure': 'late treatment toxicity', 'timeFrame': '2 years', 'description': 'late toxicity will be measured by CTCAE4.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VMAT', 'Nimotuzumab', 'Elderly Patients', 'efficacy', 'toxicity'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '29155480', 'type': 'BACKGROUND', 'citation': 'Cao C, Hu Q, Chen X. Intensity-modulated radiotherapy for elderly patients with nasopharyngeal carcinoma. Head Neck. 2018 Mar;40(3):590-595. doi: 10.1002/hed.25016. Epub 2017 Nov 20.'}, {'pmid': '23521779', 'type': 'BACKGROUND', 'citation': 'Liu H, Chen QY, Guo L, Tang LQ, Mo HY, Zhong ZL, Huang PY, Luo DH, Sun R, Guo X, Cao KJ, Hong MH, Mai HQ. Feasibility and efficacy of chemoradiotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma: results from a matched cohort analysis. Radiat Oncol. 2013 Mar 22;8:70. doi: 10.1186/1748-717X-8-70.'}, {'pmid': '24115004', 'type': 'RESULT', 'citation': 'Zhang Y, Yi JL, Huang XD, Xu GZ, Xiao JP, Li SY, Luo JW, Zhang SP, Wang K, Qu Y, Gao L. Inherently poor survival of elderly patients with nasopharyngeal carcinoma. Head Neck. 2015 Jun;37(6):771-6. doi: 10.1002/hed.23497. Epub 2015 Feb 11.'}, {'pmid': '29409313', 'type': 'RESULT', 'citation': 'Jin YN, Zhang WJ, Cai XY, Li MS, Lawrence WR, Wang SY, Mai DM, Du YY, Luo DH, Mo HY. The Characteristics and Survival Outcomes in Patients Aged 70 Years and Older with Nasopharyngeal Carcinoma in the Intensity-Modulated Radiotherapy Era. Cancer Res Treat. 2019 Jan;51(1):34-42. doi: 10.4143/crt.2017.551. Epub 2018 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and toxicity of Nimotuzumab combined with VMAT in the treatment of elderly patients with nasopharyngeal carcinoma (\\> 70 years old), and to provide high-level clinical evidence for the optimal treatment of elderly patients with nasopharyngeal carcinoma.', 'detailedDescription': 'The incidence of elderly patients with nasopharyngeal carcinoma is increasing with a rapidly ageing population. However, the prognosis is worse than that of young patients. Some patients can benefit from intensive treatment such as concurrent chemoradiotherapy, but are always with obvious toxicity. With the advancement of radiotherapy technology and the emergence of molecular targeted drugs, radiotherapy combined with Nimotuzumab has shown good therapeutic efficacy and tolerance. The investigators plan to testify VMAT combined with Nimotuzumab in elderly patients with nasopharyngeal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathology confirmed squamous cell carcinoma of nasopharynx; Aged ≥ 70 years old; Stage III-IVB diseases according to 8th AJCC Staging; Treatment for the first time; ECOG scores ≤ 1; Normal hepatic, renal and bone-marrow function; ACE-27 scores ≤2; Life expectancy≥12 weeks; Can understand and sign the consent.\n\nExclusion Criteria:\n\n* Past malignancies history (except for non-melanoma skin cancer or cervical carcinoma in situ or cured prostate cancer of early stage); Allergic to Nimotuzumab; Severe comorbidities including cardiovascular, cerebral vascular, mental and uncontrolled diabetes disease; Chemotherapy, surgery or other molecule-target treatment; Severe malnutrition.'}, 'identificationModule': {'nctId': 'NCT03915132', 'briefTitle': 'Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Phase II Trial of Nimotuzumab Combined With Volumetric Modulated Arc Therapy in Elderly Patients With Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'NCC1937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VMAT plus Nimotuzumab', 'description': 'Patients receive Nimotuzumab weekly during radiotherapy .', 'interventionNames': ['Drug: Nimotuzumab', 'Radiation: VMAT']}], 'interventions': [{'name': 'Nimotuzumab', 'type': 'DRUG', 'otherNames': ['Taixinsheng'], 'description': 'Nimotuzumab 200mg/m2 IV on d1 of a week before radiotherapy , and 100mg/m2 IV on d1 weekly for 7 cycles', 'armGroupLabels': ['VMAT plus Nimotuzumab']}, {'name': 'VMAT', 'type': 'RADIATION', 'description': 'Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx,69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume.', 'armGroupLabels': ['VMAT plus Nimotuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ye Zhang', 'role': 'CONTACT', 'email': 'drzye1983@163.com', 'phone': '8610-87787625', 'phoneExt': '13717635880'}], 'facility': 'Cancer hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 35.93305, 'lon': 111.40836}}], 'centralContacts': [{'name': 'ye zhang, MD', 'role': 'CONTACT', 'email': 'drzye1983@163.com', 'phone': '8610-87787625'}, {'name': 'Junlin Yi, M.D', 'role': 'CONTACT', 'email': 'junlinyi@sohu.com', 'phone': '861087788504'}], 'overallOfficials': [{'name': 'Ye Zhang, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CAMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Jun-Lin Yi, MD', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}