Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT04579718
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Radiotherapy Planning System Software ---- Zeus Cloud
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C509237', 'term': 'Eclipse Prosthodontic Resin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-04', 'studyFirstSubmitDate': '2020-09-26', 'studyFirstSubmitQcDate': '2020-10-04', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The qualification rate of treatment plans based on dosimetry', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'The conformability index of radiation dose to the target', 'timeFrame': '2 months'}, {'measure': 'single-field pass rate', 'timeFrame': '2 months'}, {'measure': 'composite-field pass rate', 'timeFrame': '2 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment Planning System'], 'conditions': ['Radiotherapy']}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility of Zeus Cloud TPS in the design of photon intensity modulated radiation therapy (IMRT) plan for tumors in various parts of the body.', 'detailedDescription': 'This is a self-control, multi-center non-inferiority study. Subjects meeting inclusion criteria have radiation treatment plans designed by Zeus Cloud TPS and Eclipse treatment planning software from Varian, respectively. The qualities of two plans are compared.\n\nThis is a observational study as the two plans are not executed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer;\n2. The medical imaging data (CT) of the subjects were complete and available;\n3. Between 18 and 75 years old, regardless of gender;\n\nExclusion Criteria:\n\n1. The patients had metal implants;\n2. Not suitable for clinical trials judged by investigators.'}, 'identificationModule': {'nctId': 'NCT04579718', 'briefTitle': 'A Study of Radiotherapy Planning System Software ---- Zeus Cloud', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Multicenter Study on the Feasibility of a Radiotherapy Treatment Planning System (TPS) Software---Zeus Cloud', 'orgStudyIdInfo': {'id': 'GASTO-1062'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Eclipse', 'interventionNames': ['Other: Eclipse']}, {'label': 'Zeus Cloud TPS V1.0', 'interventionNames': ['Other: Zeus Cloud TPS V1.0']}], 'interventions': [{'name': 'Zeus Cloud TPS V1.0', 'type': 'OTHER', 'description': 'Zeus Cloud TPS V1.0 is used to design the radiotherapy plan for the subjects and the plan is evaluated.', 'armGroupLabels': ['Zeus Cloud TPS V1.0']}, {'name': 'Eclipse', 'type': 'OTHER', 'description': 'Eclipse TPS of Varian company is used to design the radiotherapy plan for the subjects and the plan is evaluated.', 'armGroupLabels': ['Eclipse']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bo Qiu, MD', 'role': 'CONTACT', 'email': 'qiubo@sysucc.org.cn', 'phone': '+86-020-87343031'}], 'overallOfficials': [{'name': 'Hui Liu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, {'name': 'The Affilicated Suzhou Science and Technology Town Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hui Liu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}