Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-06-28 @ 8:27 PM
Study NCT ID:
NCT04079595
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2019-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed vs. Open Face Masks for Cranial Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2019-07-11', 'studyFirstSubmitQcDate': '2019-09-02', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient discomfort with the two immobilization masks', 'timeFrame': 'Change in patient discomfort through the course of radiation therapy, up to 6 weeks', 'description': 'Patient discomfort measured with the Visual Analogue Scale (VAS) 0-10 with "no discomfort" (scored as 0) and "extreme discomfort" (scored as 10).'}, {'measure': 'Mask preference', 'timeFrame': 'At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation', 'description': 'Mask preference measured with the Yes/No questionnaire. Upon completion of radiation therapy patients will be asked which of the two immobilization masks they prefer - either Yes or No to one of the used masks.'}], 'secondaryOutcomes': [{'measure': 'Treatment set-up accuracy', 'timeFrame': 'Through the course of radiation therapy, up to 6 weeks', 'description': 'Measured with planar kilovoltage (kV) imaging'}, {'measure': 'Treatment intra-fraction accuracy', 'timeFrame': 'Through the course of radiation therapy, up to 6 weeks', 'description': 'Measured with an optic surface imaging (OSI) system'}, {'measure': 'Immobilization-mask-induced severe adverse events during treatment', 'timeFrame': 'From the baseline to 3 months post-treatment', 'description': 'Measured with CTCAE version 5.0'}, {'measure': 'Location of discomfort on the head/face', 'timeFrame': 'Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks', 'description': 'Measured with the questionnaire consisting of a head/face diagram divided in 8 regions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Tumor', 'Brain Metastases', 'Small Cell Lung Cancer', 'Meningioma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/38677329/', 'label': 'Randomized self-controlled study comparing open-face vs. closed immobilization masks in fractionated cranial radiotherapy'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate whether open-face masks improve patient comfort/preference whilst maintaining immobilization performance as known for closed masks in patients undergoing whole or partial cranial radiotherapy.', 'detailedDescription': 'Upon randomization, patients will be begin treatment either with an open-face mask (A) or closed mask (B). Two individual immobilization masks - the open-face and closed masks - will be fabricated for every single patient. During the 1st half of treatment the randomly assigned mask will be used followed by using another mask for the 2nd half of treatment. Discomfort/pain/anxiety and mask preference will be scored during treatment with a questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent according to Swiss law and International Council for Harmonization (ICH)/Good Clinical Practice (GCP) regulations before any trial specific procedures;\n* Indication for cranial radiotherapy irrespective of tumor type;\n* Age: ≥ 18 years old;\n* Karnofsky performance status ≥70;\n* Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.\n\nExclusion Criteria:\n\n* Cranial radiotherapy in less than 10 fractions;\n* Prior brain irradiation;\n* Inability to complete magnetic resonance imaging (MRI) procedure due to claustrophobic anxiety;\n* Women who are pregnant or breast feeding;\n* Intention to become pregnant during the course of the trial;\n* Lack of safe contraception;\n* Known or suspected non-compliance, drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT04079595', 'briefTitle': 'Closed vs. Open Face Masks for Cranial Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Randomized Controlled Trial Comparing Closed vs. Open Face Masks for Cranial Radiotherapy', 'orgStudyIdInfo': {'id': 'Comfort RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-faced head immonbilization masks', 'description': 'Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face', 'interventionNames': ['Device: Head immobilization mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Closed-face head immobilization masks', 'description': 'Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed', 'interventionNames': ['Device: Head immobilization mask']}], 'interventions': [{'name': 'Head immobilization mask', 'type': 'DEVICE', 'description': 'Immobilization', 'armGroupLabels': ['Closed-face head immobilization masks', 'Open-faced head immonbilization masks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Department of Radiation Oncology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Matthias Guckenberger, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Department of Radiation Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}