Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-26 @ 4:07 PM
Study NCT ID:
NCT05289466
Status:
RECRUITING
Last Update Posted:
2023-04-11
First Post:
2022-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, Non-randomized, Single-arm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2022-03-08', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.', 'timeFrame': '5 years', 'description': "The BREAST-Q is a validated patient-reported outcome measure of breast related satisfaction and quality of life, including psychosocial, sexual well-being, and physical domains. Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models."}, {'measure': 'Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.', 'timeFrame': '5 years', 'description': "Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models."}, {'measure': 'Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale', 'timeFrame': '5 years', 'description': "Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models."}, {'measure': 'Perioperative complications as documented using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (CTCAE.v5) scoring system.', 'timeFrame': '5 years', 'description': "Data for perioperative complications will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models."}], 'secondaryOutcomes': [{'measure': 'Effectiveness of partial mastectomy with IORT, measured by local recurrence.', 'timeFrame': '5 years', 'description': 'Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.'}, {'measure': 'Effectiveness of partial mastectomy with IORT, measured by regional recurrence.', 'timeFrame': '5 years', 'description': 'Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.'}, {'measure': 'Effectiveness of partial mastectomy with IORT, measured by distant recurrence.', 'timeFrame': '5 years', 'description': 'Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.'}, {'measure': 'Effectiveness of partial mastectomy with IORT, measured by mastectomy rate.', 'timeFrame': '5 years', 'description': 'Mastectomy rate will be measured by counting those who receive IORT and whose final pathology shows node positive or multifocal disease span \\>3cm post IORT, are advised to have mastectomy and have mastectomy.'}, {'measure': 'Effectiveness of partial mastectomy with IORT, measured by disease-specific survival.', 'timeFrame': '5 years', 'description': 'Disease specific survival will be measured based on dates and causes of death.'}, {'measure': 'Effectiveness of partial mastectomy with IORT, measured by overall survival', 'timeFrame': '5 years', 'description': 'Overall survival will be measured based on dates and causes of death.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['IORT-Intra-Operative Radiation Therapy']}, 'descriptionModule': {'briefSummary': 'Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Biological Female', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 50 y.o.\n* Histologically proven in situ and invasive ductal or lobular breast recurrence\n* Prior history of whole breast/chest wall radiation therapy\n* Disease span ≤ 3 cm, unifocal\n* No nodal disease (N0)\n* No evidence of metastatic disease (M0)\n* Time from initial BCT should be ≥ 1 year\n* Patients have refused the standard of care of mastectomy\n* Skin distance of ≥ 0.8 cm between applicator and skin\n\nExclusion Criteria:\n\n* Multifocal and/or multicenter recurrence\n\n * N1-3 status: Regional cytological or histologically proven node recurrence\n * M1 status: Metastatic disease\n * cT4 (Skin or muscle involvement) or Paget's disease of the nipple\n * Patients undergoing mastectomy\n * Patients undergoing neoadjuvant systemic therapy\n * Connective tissue disease or scleroderma, contraindicating radiotherapy"}, 'identificationModule': {'nctId': 'NCT05289466', 'briefTitle': 'Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.', 'organization': {'class': 'OTHER', 'fullName': "Saint John's Cancer Institute"}, 'officialTitle': 'Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation', 'orgStudyIdInfo': {'id': 'JWCI OBCS WITH IORT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single-arm', 'description': 'Intraoperative Radiotherapy (Xoft, 20 Gy single dose)', 'interventionNames': ['Radiation: Intraoperative Radiotherapy', 'Procedure: Oncoplastic partial mastectomy']}], 'interventions': [{'name': 'Intraoperative Radiotherapy', 'type': 'RADIATION', 'description': 'Intraoperative Radiotherapy (Xoft, 20 Gy single dose)', 'armGroupLabels': ['Single-arm']}, {'name': 'Oncoplastic partial mastectomy', 'type': 'PROCEDURE', 'description': 'Breast Conserving Therapy', 'armGroupLabels': ['Single-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janie Grumley, MD', 'role': 'CONTACT', 'email': 'janie.grumley@providence.org', 'phone': '310-582-7100'}, {'name': 'Janie Weng Grumley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Robert Wollman, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Providence Saint John's Hospital", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'centralContacts': [{'name': 'Janie Weng Grumley, MD', 'role': 'CONTACT', 'email': 'janie.grumley@providence.org', 'phone': '(310)-582-7100'}, {'name': 'Robert Wollman, MD', 'role': 'CONTACT', 'email': 'robert.wollman@providence.org', 'phone': '(310)-829-8913'}], 'overallOfficials': [{'name': 'Janie L Weng Grumley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Saint John's Cancer Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Saint John's Cancer Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director, Margie Petersen Breast Center; Associate Professor of Surgery, Saint John's Cancer Institute", 'investigatorFullName': 'Janie Grumley', 'investigatorAffiliation': "Saint John's Cancer Institute"}}}}