Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT06215495
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2023-10-30', 'studyFirstSubmitQcDate': '2024-01-18', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years', 'description': "confirm if the participant's cancer progresses or he/she dies every time back to the hospital during screening and follow-up"}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 3 year', 'description': 'confirm if the participant dies every time back to the hospital during screening and follow-up'}, {'measure': 'European organisation for research and treatment of cancer QLQ-C30 (EORTC-QLQ-C30)', 'timeFrame': 'through study completion, up to 3 years', 'description': 'EORTC-QLQ-C30 questionnaire'}, {'measure': 'radiotherapy complication incidence', 'timeFrame': 'through study completion, up to 3 years'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Toxicity', 'MRI Simulated Positioning', 'High Grade Glioma', 'Progression-free Survival', 'Overall Survival']}, 'descriptionModule': {'briefSummary': 'The main question it aims to answer are:\n\n1. whether the new target delineation scheme can improve Progression-free Survival\n2. whether it can reduce the incidence of radiation complications in high-grade glioma patients.\n\nParticipants in trial group will be performed radiotherapy of new target delineation method after the completion of the operation within 4-6 weeks., while participants in the control group be performed radiotherapy of EORTC(European organisation for research and treatment of cancer) target delineation method.Temozolomide 75 mg / ( m² · d ) will be given to both groups of patients during radiotherapy. After radiotherapy, its dose changes to 150 \\~ 200 mg / ( m² · d ) for 5 days and stopped for 23 days as a cycle. There are 6 cycles in total.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. High-grade glioma (2021 WHO grade III or IV)\n2. Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70\n3. result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential\n4. The patient voluntarily joined this study and signed an informed consent form\n5. Willing to return for follow-up\n6. Willing to provide tissue and blood samples for this research\n7. Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency)\n8. Radiotherapy within 4-6 weeks after surgery\n9. No contraindications for taking temozolomide\n\nExclusion Criteria:\n\n1. Low-grade glioma(2021 WHO grade I or II)\n2. had or having other type of malignant cancers\n3. not having been performed gross total resection of tumor\n4. Severe active comorbidities, systemic diseases or other serious comorbidities that would render the patient unsuitable for participation in this study or seriously interfere with the appropriate evaluation of the safety and toxicity of the prescribed regimen in the judgment of the investigator, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, or mental illness；\n5. Baseline MRI indicates a previous or recent risk of cerebral hemorrhage or hernia;\n6. Pregnancy or lactation, or pregnancy or childbirth during the expected trial period(from pre-screening or screening visits until 120 days after the last trial treatment)\n7. Unable to perform brain magnetic resonance imaging;\n8. Allergic to CT contrast agent, unable to perform enhanced CT examination;\n9. Remote transfer;\n10. Medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma'}, 'identificationModule': {'nctId': 'NCT06215495', 'briefTitle': 'A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'A Novel Target Delineation Scheme Based on RTOG(Radiation Therapy Oncology Group) and EORTC(European Organisation for Research and Treatment of Cancer) Guidelines Impact on Survival Time and Radiotherapy Complications in High-grade Glioma Patients: a Single-center Randomized Single-blind Clinical Trial', 'orgStudyIdInfo': {'id': '2024-KY-010-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'reduced CTV (clinical target volume) and PTV (planning target volume)', 'interventionNames': ['Radiation: reduced target volume']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EORTC CTV (clinical target volume) and PTV (planning target volume)', 'interventionNames': ['Radiation: EORTC (European organisation for research and treatment of cancer) target volume']}], 'interventions': [{'name': 'reduced target volume', 'type': 'RADIATION', 'description': 'Delineate residual tumor(GTVp) and tumor bed(GTVtb) on enhanced contrast CT-MRI(T2 fluid attenuated inversion recovery, T2 FLAIR) fusion images. GTVtb and GTVp are expanded by 1cm to CTV\\_6000.\n\nThe clinical target volume\\_6000 cGy (CTV\\_6000) is partially reduced beyond the skull and midline. According to the CT-MRI(T2 FLAIR) fusion images, the edema area that cannot be seen on contrast-enhanced CT and only can be seen on MRI should be included.\n\nIf CTV\\_6000 includes thalamus, basal ganglia, brainstem or motor cortex, dose of these areas will be limited no more than 54Gy', 'armGroupLabels': ['reduced CTV (clinical target volume) and PTV (planning target volume)']}, {'name': 'EORTC (European organisation for research and treatment of cancer) target volume', 'type': 'RADIATION', 'description': 'delineate according to EORTC guideline', 'armGroupLabels': ['EORTC CTV (clinical target volume) and PTV (planning target volume)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yujing Tan, Doctor', 'role': 'CONTACT', 'email': 'tanyujing-1981@163.com', 'phone': '+8662782356'}], 'facility': 'southern medical university affiliated Zhujiang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yujing Tan, Doctor', 'role': 'CONTACT', 'email': 'tanyujing-1981@163.com', 'phone': '+8613560347303'}], 'overallOfficials': [{'name': 'Yujing Tan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '+8613560347303'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}