Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT03040804
Status:
TERMINATED
Last Update Posted:
2021-11-01
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}, {'id': 'D016575', 'term': 'Hidradenitis'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'srcohen@montefiore.org', 'phone': '7189208352', 'title': 'Steven R. Cohen, MD, MPH', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Two participants were observed in relation to baseline radiotherapy treatment for an average of 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose Radiotherapy', 'description': 'Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week\n\nLow dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.\n\nNo adverse event reported to date.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With HS Who Experience Treatment-related Grade ≥3 Adverse Events During Radiotherapy or Within 3 Months of Radiotherapy Completion, Assessed Using CTCAE Version 4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Radiotherapy', 'description': 'Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week\n\nLow dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'follow up for 3-6 months post treatment', 'description': 'Number of participants with HS who experience treatment-related CTCAE version 4.0 Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion. Common Terminology Criteria for Adverse Events (CTCAE) is an internationally accepted standard for defining and categorizing adverse events based on severity of reported adverse events. The grading scheme is from 1 (least severe) to 5 (most severe). For radiotherapy associated adverse events, CTCAE version 4.0 will be applied to "Rash: dermatitis associated with radiation".\n\nGrade 1. Mild: Faint erythema or dry desquamation. Grade 2. Moderate: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema.\n\nGrade 3. Severe: Moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion.\n\nGrade 4. Life threatening: Skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site.\n\nGrade 5', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with Hidradenitis Suppurativa (HS) Hurley Stage 2-3.'}, {'type': 'SECONDARY', 'title': 'Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Radiotherapy', 'description': 'Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week\n\nLow dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.'}], 'timeFrame': '6 months - 1 year post treatment', 'description': "Evaluation of the efficacy of radiotherapy in improvement of patient's quality of life using patient reported outcome measures, including pain interference and physical functioning at 3 months (and optionally at 6 months and 12 months) after treatment.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to COVID-19 pandemic, patient safety was prioritized and the study was terminated early. Participant outcome measures were not performed.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Radiotherapy', 'description': 'Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week\n\nLow dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.'}], 'timeFrame': '3-6 months post treatment', 'description': 'Hematoxylin and Eosin (H\\&E) stain and immunohistochemistry stains will be performed on skin biopsy specimens to investigate histological changes following radiotherapy for advanced hidradenitis suppurativa lesions.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to COVID-19 pandemic, patient safety was prioritized and the study was terminated early. Participant outcome measures were not completed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose Radiotherapy', 'description': 'Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week\n\nLow dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose Radiotherapy', 'description': 'Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week\n\nLow dose Radiotherapy: Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '67', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Improvement in hidradenitis suppurativa lesion size', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-05', 'size': 642411, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-26T12:25', 'hasProtocol': True}, {'date': '2016-07-13', 'size': 249289, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-08-26T12:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Simon two-stage design. In the first stage, 6 patients will be enrolled. If the patients in the study do not meet the termination criteria then the study will extend to a second stage and a maximum of 20 patients will be enrolled.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Infeasibility to continue study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2017-01-30', 'resultsFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-22', 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With HS Who Experience Treatment-related Grade ≥3 Adverse Events During Radiotherapy or Within 3 Months of Radiotherapy Completion, Assessed Using CTCAE Version 4.0', 'timeFrame': 'follow up for 3-6 months post treatment', 'description': 'Number of participants with HS who experience treatment-related CTCAE version 4.0 Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion. Common Terminology Criteria for Adverse Events (CTCAE) is an internationally accepted standard for defining and categorizing adverse events based on severity of reported adverse events. The grading scheme is from 1 (least severe) to 5 (most severe). For radiotherapy associated adverse events, CTCAE version 4.0 will be applied to "Rash: dermatitis associated with radiation".\n\nGrade 1. Mild: Faint erythema or dry desquamation. Grade 2. Moderate: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema.\n\nGrade 3. Severe: Moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion.\n\nGrade 4. Life threatening: Skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site.\n\nGrade 5'}], 'secondaryOutcomes': [{'measure': 'Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS).', 'timeFrame': '6 months - 1 year post treatment', 'description': "Evaluation of the efficacy of radiotherapy in improvement of patient's quality of life using patient reported outcome measures, including pain interference and physical functioning at 3 months (and optionally at 6 months and 12 months) after treatment."}, {'measure': 'Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions.', 'timeFrame': '3-6 months post treatment', 'description': 'Hematoxylin and Eosin (H\\&E) stain and immunohistochemistry stains will be performed on skin biopsy specimens to investigate histological changes following radiotherapy for advanced hidradenitis suppurativa lesions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hidradenitis suppurativa', 'HS', 'radiotherapy'], 'conditions': ['Hidradenitis Suppurativa', 'Hidradenitis']}, 'descriptionModule': {'briefSummary': 'To establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. Patients will receive radiotherapy treatment over one week and then they will be followed for the next three months.', 'detailedDescription': 'This is a phase I clinical trial using a Simon-two stage design to establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa (HS). In the first six months, 6 patients will be enrolled, if the patients in the study do not meet the termination criteria, then the study will extend to a second stage. A maximum of 20 patients will be enrolled. Patients will be treated with skin-directed radiotherapy, using a total prescription dose of 7.5 Gy in five fractions of 1.5 Gy over one week. Patients will then be seen in the HS specialty clinic at Montefiore Medial Center for at least three months. Quality of life changes, immunohistochemical changes, and cutaneous discharge will also be evaluated during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Hidradenitis Suppurativa made at the Montefiore Hidradenitis Suppurativa Treatment Center, with Hurley Stage 2-3 (defined as recurrent abscesses or boils with diffuse or broad involvement, multiple interconnected sinus tracts in the whole area)\n* Failed maximal medical therapy for Hidradenitis Suppurativa or ineligible for "standard" medical therapy or surgery\n* Age \\> 20 years\n* Women of childbearing age: must have a negative pregnancy test within 72 hours prior to the start of study therapy and agree to an adequate method of contraception throughout treatment and for at least 4 weeks after study contraception.\n\nExclusion Criteria:\n\n* Pregnant women\n* Individuals \\< 20 years old'}, 'identificationModule': {'nctId': 'NCT03040804', 'acronym': 'RTHS', 'briefTitle': 'Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'A Phase I Study of Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': '2016-7228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose Radiotherapy', 'description': 'Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week', 'interventionNames': ['Radiation: Low dose Radiotherapy']}], 'interventions': [{'name': 'Low dose Radiotherapy', 'type': 'RADIATION', 'otherNames': ['Brachytherapy'], 'description': 'Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.', 'armGroupLabels': ['Low Dose Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Steven R Cohen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Dermatology at Montefiore', 'investigatorFullName': 'Steven R Cohen', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}