Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT03530605
Status:
WITHDRAWN
Last Update Posted:
2020-09-02
First Post:
2018-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective group (non-randomized) compared to historical matched controls'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study never initiated, PI left institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival Time', 'timeFrame': '4 years', 'description': 'Overall survival time'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival Time', 'timeFrame': '2 years', 'description': 'Progression-free survival time'}, {'measure': 'One-Year Survival Rate', 'timeFrame': '1 year', 'description': 'One-year survival rate'}, {'measure': 'Radiographic Response Rate', 'timeFrame': '2 years', 'description': 'Tumor response by MRI measurement'}, {'measure': 'Steroid & Antiepileptic Use', 'timeFrame': '2 years', 'description': 'use of concomitant steroids and antiepileptic use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PCNSL, primary central nervous system lymphoma'], 'conditions': ['Central Nervous System Neoplasms, Primary']}, 'descriptionModule': {'briefSummary': 'This study will compare the overall survival (OS) time of elderly patients who would not tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those treated with whole-brain radiotherapy alone.\n\nStandard treatment of primary central nervous system lymphoma (PCNSL) for patients with good performance status involves high-dose methotrexate-based chemotherapy regimens and whole-brain radiation therapy (WBXRT). Although up to 20% of patients with PCNSL are 80 years of age or older, little data exist with regard to optimal treatment of this patient population and they often do not qualify for clinical trials. In addition, elderly patients have a poorer rate of complete and partial response and increased risk of toxicity when treated with standard chemotherapy regimens. Though a consensus does not exist, radiotherapy alone is often used in these patients to minimize toxic effects of more aggressive chemotherapies.\n\nThe Optune TTF device has proven effective in treating high-grade gliomas and is currently being investigated to treat meningiomas and metastatic lesions in the brain as well as other tumor types elsewhere in the body. It is generally well tolerated with no known systemic side effects, producing only an occasional local skin reaction. The mechanism of action is independent of tumor type and therefore may be effective in treating lymphoma as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological de novo diagnosis of PCNSL\n* Tumor located in the supra-tentorial brain region\n* Karnofsky performance score of 70 or above\n* Ineligible for chemotherapy due to age or other co-morbidities\n* Life expectancy of at least 3 months\n* Patient has a caretaker willing to assist with study compliance\n* Patient is able to provide written consent on their own behalf\n\nExclusion Criteria:\n\n* Second or subsequent recurrence of PCNSL\n* Patient wishes to receive systemic treatment\n* Implanted electronic medical device in the brain (deep brain stimulator, vagus nerve stimulator, programmable shunt, etc.)\n* Skull defect without replacement\n* Prior radiation, surgery, or chemotherapy for PCNSL within the 4 weeks prior to enrollment\n* Patient unable to comply with Optune device treatment or the study follow- up schedule\n* Active participation in another therapeutic clinical trial\n* Patient unable to provide written consent on their own behalf'}, 'identificationModule': {'nctId': 'NCT03530605', 'briefTitle': 'Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma', 'organization': {'class': 'OTHER', 'fullName': "Saint Luke's Health System"}, 'officialTitle': 'Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma', 'orgStudyIdInfo': {'id': 'Optune TTF in PCNSL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optune TTF Device', 'description': 'Optune TTF treatment', 'interventionNames': ['Device: Optune TTF device']}, {'type': 'NO_INTERVENTION', 'label': 'Historical matched control', 'description': 'age-matched historical controls'}], 'interventions': [{'name': 'Optune TTF device', 'type': 'DEVICE', 'description': 'portable device which produces electrical fields', 'armGroupLabels': ['Optune TTF Device']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Saint Luke's Health System", 'class': 'OTHER'}, 'collaborators': [{'name': 'NovoCure Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}