Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-02-10 @ 12:07 PM
Study NCT ID:
NCT03312868
Status:
TERMINATED
Last Update Posted:
2022-04-06
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010954', 'term': 'Plasmacytoma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Burocracy and funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2017-10-12', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dosimetric prognostic factors', 'timeFrame': '5 years', 'description': 'Describe and explore dosimetric factors for local control and toxicities'}], 'primaryOutcomes': [{'measure': 'Progression-free survival for multiple myeloma', 'timeFrame': '5 years', 'description': 'Progression-free survival for multiple myeloma at 5 years evaluation in patients undergoing SBRT for solitary plasmacytoma compared to a retrospective cohort of patients'}], 'secondaryOutcomes': [{'measure': 'Local control rate', 'timeFrame': '5 years', 'description': 'Local progression-free survival'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Overall survival'}, {'measure': 'Survival free of bone events', 'timeFrame': '5 Years', 'description': 'Those are described as fractures, osteomyelitis, necessity of surgery, deformation of bone or ironic bone pain'}, {'measure': 'Toxicities', 'timeFrame': '5 Years', 'description': 'Toxicities in the scale of common criteria of toxicity by the National Cancer Institute CTCAE v4'}, {'measure': 'Quality of Life', 'timeFrame': '5 years', 'description': 'Quality of life of patients in the prospective cohort using the EORTC QLQ-30 questionnaire'}, {'measure': 'Quality of Life', 'timeFrame': '5 years', 'description': 'Quality of life of patients in the prospective cohort using the Short Form Health Survey 36 v.2 (SF-36) questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stereotactic Body Radiotherapy'], 'conditions': ['Plasmacytoma']}, 'referencesModule': {'references': [{'pmid': '6153562', 'type': 'RESULT', 'citation': 'Mill WB, Griffith R. The role of radiation therapy in the management of plasma cell tumors. Cancer. 1980 Feb 15;45(4):647-52. doi: 10.1002/1097-0142(19800215)45:43.0.co;2-e.'}, {'pmid': '25987031', 'type': 'RESULT', 'citation': 'Li QW, Niu SQ, Wang HY, Wen G, Li YY, Xia YF, Zhang YJ. Radiotherapy Alone is Associated with Improved Outcomes Over Surgery in the Management of Solitary Plasmacytoma. Asian Pac J Cancer Prev. 2015;16(9):3741-5. doi: 10.7314/apjcp.2015.16.9.3741.'}, {'pmid': '6780494', 'type': 'RESULT', 'citation': 'Mendenhall CM, Thar TL, Million RR. Solitary plasmacytoma of bone and soft tissue. Int J Radiat Oncol Biol Phys. 1980 Nov;6(11):1497-501. doi: 10.1016/0360-3016(80)90006-1. No abstract available.'}, {'pmid': '16229966', 'type': 'RESULT', 'citation': 'Ozsahin M, Tsang RW, Poortmans P, Belkacemi Y, Bolla M, Dincbas FO, Landmann C, Castelain B, Buijsen J, Curschmann J, Kadish SP, Kowalczyk A, Anacak Y, Hammer J, Nguyen TD, Studer G, Cooper R, Sengoz M, Scandolaro L, Zouhair A. Outcomes and patterns of failure in solitary plasmacytoma: a multicenter Rare Cancer Network study of 258 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):210-7. doi: 10.1016/j.ijrobp.2005.06.039. Epub 2005 Oct 17.'}, {'pmid': '17032388', 'type': 'RESULT', 'citation': 'Wong ET, Lu XQ, Devulapalli J, Mahadevan A. Cyberknife radiosurgery for basal skull plasmacytoma. J Neuroimaging. 2006 Oct;16(4):361-3. doi: 10.1111/j.1552-6569.2006.00062.x.'}, {'pmid': '24773479', 'type': 'RESULT', 'citation': 'Chang UK, Lee DH, Kim MS. Stereotactic radiosurgery for primary malignant spinal tumors. Neurol Res. 2014 Jun;36(6):597-606. doi: 10.1179/1743132814Y.0000000381. Epub 2014 Apr 28.'}, {'pmid': '18725106', 'type': 'RESULT', 'citation': 'Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This project aims to propose a new approach in the treatment of solitary plasmacytoma: hypofractionated irradiation alone with stereotactic technique that may contribute to the successful treatment of this disease.\n\nThis work aims to apply this new technique with the primary objective of reducing the progression-free survival for multiple myeloma of patients treated for solitary plasmacytoma, as well as quantify overall survival, local control, toxicities and quality of life in a phase I trial / II.', 'detailedDescription': 'Solitary plasmacytoma is a rare disease whose treatment has not evolved much in the last decades. The role of radiotherapy in the curative treatment of this entity was defined in a major publication in the 1980s and has since been proven to be the best practice in several other comparative trials, mostly retrospective. The radiotherapy dose of curative intent has also been described over the same period and remains unchanged to this day. Thus, local control, disease cure rate, and rate and progression time for multiple myeloma have been unaffected for almost 30 years.\n\nRadiobiology of plasmacytoma cells is also not widely studied. The alpha / beta ratio, which defines the pattern of response of this disease to radiotherapy fractions and its response time, is also not well described. However, it is believed to be smaller in comparison to other hematological malignancies due to reports of cases of intrinsic radioresistance and late recurrence and reports of success with hypofractionated dose in isolated cases where stereotactic techniques were used such as base of skull and spine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven plasmacytic for the index lesion;\n* Age between 18 and 85 years;\n* ECOG scale performance of 0 to 2\n\nExclusion Criteria:\n\n* Refuse to sign or inability to understand the term of free and informed commitment (TCLE);\n* Technical limitations for treatment with SBRT among which is cited, but not limited to, weight greater than 115 Kg, inability to abduct limb to be treated in appendicular bone plasmocytomas, intolerable pain to remain in treatment position;\n* Criteria for multiple myeloma at diagnosis: more than 10% of plasma cells in bone marrow biopsy, hypercalcemia greater than 11.5 mg/dL, serum creatinine greater than 2mg/dL, creatinine clearance less than 40mL/min , Hemoglobin less than 10g/dL.\n* Previous cancer diagnosis and treatments;\n* Previous bone events such as fractures and osteomyelitis in the bone in which the index lesion is found;\n* Prior autoimmune diseases, even if controlled;\n* Extra-medullary plasmacytoma requiring elective treatment of lymph node drainage;\n* Current pregnancy'}, 'identificationModule': {'nctId': 'NCT03312868', 'briefTitle': 'Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Phase I/II Trial of Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma', 'orgStudyIdInfo': {'id': 'NP 1122/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective Arm', 'description': 'Prospective arm with patients being treated with SBRT', 'interventionNames': ['Radiation: SBRT']}], 'interventions': [{'name': 'SBRT', 'type': 'RADIATION', 'description': 'Stereotactic Body Radiotherapy', 'armGroupLabels': ['Prospective Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Sao Paulo Cancer Institute', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Geovanne Pedro Mauro', 'investigatorAffiliation': 'Instituto do Cancer do Estado de São Paulo'}}}}