Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-21 @ 6:23 AM
Study NCT ID:
NCT02629757
Status:
UNKNOWN
Last Update Posted:
2018-02-23
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-21', 'studyFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Over-all survival', 'timeFrame': '5-year'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '5-year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High-grade glioma', 'chemotherapy', 'β-elemene'], 'conditions': ['Anaplastic Oligoastrocytoma', 'Anaplastic Astrocytoma', 'Glioblastoma']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.', 'detailedDescription': 'This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma. β-elemene will be given 600mg/d,d1-14,q28 days for 6 cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Page 3 of 4 \\[DRAFT\\] - Arms Assigned Interventions\n\n * Temodar Experimental: temozolomide +α-IFN Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN： 3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m\\^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m\\^2 daily of subsequent cycles Drug: Temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days\n\nOther Names:\n\n• Temodar Drug: α-IFN 3mIU (3million) D1，3，5\n\nOther Names:\n\nMinimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy Volunteers?: No\n\nCriteria: Inclusion Criteria:\n\n* Age: 18 years to 75 years\n* complete remission patients of newly diagnosed WHO III-IV glioma following standard treatment\n* Karnofsky Performance Score ≥ 60\n* Adequate bone marrow, liver and renal function\n* Ability of subject to understand character and individual consequences of the clinical trial\n* Written informed consent\n* anticipating survival ≥2 months\n\nExclusion Criteria:\n\n* Refusal to participate the study\n* Known hypersensitivity or contraindication to temozolomide\n* Incompletely radiation\n* Pregnant or lactating females\n* Malignant tumor other than brain tumor\n* Contraindicated for MRI examination\n* Unable to comply with the follow-up studies of this trial\n* Purulent and chronic infected wounds\n* Uncontrolled psychotic disorders or epilepsy\n* progression disease'}, 'identificationModule': {'nctId': 'NCT02629757', 'acronym': 'β-elemene', 'briefTitle': 'A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Study on β-elemene as Maintain Treatment for Complete Remission Patients of Newly Diagnosed Malignant Gliomas Following Standard Treatment', 'orgStudyIdInfo': {'id': 'CSNO2015001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'β-elemene', 'description': 'β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.', 'interventionNames': ['Drug: β-elemene']}], 'interventions': [{'name': 'β-elemene', 'type': 'DRUG', 'description': 'β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles', 'armGroupLabels': ['β-elemene']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhong-ping Chen', 'role': 'CONTACT', 'phone': '+86-20-87343310'}, {'name': 'Chengcheng Guo', 'role': 'CONTACT', 'phone': '+86-20-87343890'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhong-ping CHEN', 'role': 'CONTACT', 'email': 'chenzhp@sysucc.org.cn', 'phone': '+86-20-87343310'}, {'name': 'Chengceng Guo', 'role': 'CONTACT', 'email': 'guochch@sysucc.org.cn', 'phone': '+86-20-87343890'}], 'overallOfficials': [{'name': 'Zhong-ping CHEN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhongping Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}