Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 4:11 PM
Study NCT ID:
NCT05179161
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2021-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Setup error', 'timeFrame': 'During the intervention', 'description': 'Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging'}], 'secondaryOutcomes': [{'measure': 'Patient comfort', 'timeFrame': 'immediately after the intervention', 'description': 'Patient comfort as assessed by questionnaire'}, {'measure': 'Setup Time', 'timeFrame': 'During the intervention', 'description': 'Time taken for setting up the patient for each fraction'}, {'measure': 'Reproducibility of DIBH', 'timeFrame': 'At baseline', 'description': 'The reproducibility and stability of deep inspiration breathhold is investigated by performing multiple breathhold manoevres during CT imaging at baseline, and comparing the relative geometric position of organs between on the acquired images for each patient. This will be evaluated by calculating the overlap index and dice similarity coefficien between these images.'}, {'measure': 'Acute toxicity', 'timeFrame': '6 months after treatment end', 'description': 'Acute side effects due to radiotherapy using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 toxicity scoring system, scoring toxicities from grade 0 (no toxicity) to grade 5 (death)'}, {'measure': 'Dose to target and dose to organs at risk', 'timeFrame': 'Before treatment initiation after CT simulation', 'description': "Analysis is dose using the Dose-volume histogram (DVH) of targets and organs at risk, as obtained on CT simulation images. These DVH's are used to assess amount of radiation received by each organ and treatment target and assess the risk of treatment failure or treatment harm."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prone positioning', 'Prone crawl position', 'Radiotherapy', 'Whole breast irradiation', 'Setup errors', 'Patient comfort', 'Setup time', 'Deep inspiration breathhold', 'Dosimetry'], 'conditions': ['Breast Cancer Female']}, 'referencesModule': {'references': [{'pmid': '33009448', 'type': 'RESULT', 'citation': 'Deseyne P, Speleers B, De Neve W, Boute B, Paelinck L, Vakaet V, Van Hulle H, Schoepen M, Stouthandel M, Van Greveling A, Post G, Detand J, Monten C, Depypere H, Veldeman L. Crawl positioning improves set-up precision and patient comfort in prone whole breast irradiation. Sci Rep. 2020 Oct 2;10(1):16376. doi: 10.1038/s41598-020-72702-3.'}, {'pmid': '35115610', 'type': 'DERIVED', 'citation': 'Deseyne P, Speleers B, Paelinck L, De Gersem W, De Neve W, Schoepen M, Van Greveling A, Van Hulle H, Vakaet V, Post G, Monten C, Depypere H, Veldeman L. Reproducibility of repeated breathhold and impact of breathhold failure in whole breast and regional nodal irradiation in prone crawl position. Sci Rep. 2022 Feb 3;12(1):1887. doi: 10.1038/s41598-022-05957-7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for WBI without LNI after breast-conserving surgery will be included after signing informed consent.', 'detailedDescription': 'This is a phase II non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. Patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 Gy in 15 fractions of 2.67 Gy.\n\nThe trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. Feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated.\n\nThis is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female patients\n* Non-metastasized breast carcinoma\n* Multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer\n* Prone WBI without LNI indicated according to the department's guidelines, treatment schedule of at least 15 fractions\n* Age ≥ 18 years\n* Informed consent obtained, signed and dated before specific protocol procedures\n\nExclusion Criteria:\n\n* \\< 18 years old\n* Mastectomy\n* Need for LNI\n* Bilateral breast irradiation\n* Partial breast irradiation\n* Unable to be treated in prone position\n* Less than 15 treatment fractions planned\n* Situs inversus\n* Pregnant or breastfeeding\n* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study\n* Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study"}, 'identificationModule': {'nctId': 'NCT05179161', 'briefTitle': 'Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery', 'orgStudyIdInfo': {'id': 'EC-UZ-2016/0351'}, 'secondaryIdInfos': [{'id': 'B670201628048', 'type': 'REGISTRY', 'domain': 'Belgian Registration Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prone crawl position', 'description': 'Patients are placed in the prone crawl position for whole breast irradiation and are treated with 15 x 2,67 Gy (± boost treatment if required as per international guidelines)', 'interventionNames': ['Device: Prone crawl positioning']}], 'interventions': [{'name': 'Prone crawl positioning', 'type': 'DEVICE', 'description': 'Breast cancer patients are placed in a prone position with the ipsilateral arm besides the body rather than extended besides the head on a dedicated couch that provides the required support for maintaining this position.', 'armGroupLabels': ['Prone crawl position']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Liv Veldeman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing patient data is not planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}