Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00267033
Status:
COMPLETED
Last Update Posted:
2008-12-02
First Post:
2005-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-01', 'studyFirstSubmitDate': '2005-12-19', 'studyFirstSubmitQcDate': '2005-12-19', 'lastUpdatePostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy.', 'timeFrame': '3 months after radiotherapy'}, {'measure': 'Response will be scored as complete (no pain), partial (improvement of < 2 points in BPI), stable (+/- 1 point change in BPI) or progressive (> 2 point worsening of BPI).', 'timeFrame': 'during the study'}, {'measure': 'Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures', 'timeFrame': 'during the study'}], 'secondaryOutcomes': [{'measure': 'Evaluation of pain relief one month after radiotherapy', 'timeFrame': 'one month after radiotherapy'}, {'measure': 'BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life.', 'timeFrame': 'during the study'}, {'measure': 'The incidence of vertebral pathologic fracture will be registered.', 'timeFrame': 'one month after radiotherapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neoplasm Metastasis', 'Bone Neoplasms', 'Pain', 'Radiotherapy', 'Vertebroplasty', 'Combined modality therapy'], 'conditions': ['Osseous Spine Metastases']}, 'referencesModule': {'references': [{'pmid': '15928300', 'type': 'BACKGROUND', 'citation': 'Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.'}, {'pmid': '8633152', 'type': 'BACKGROUND', 'citation': 'Weill A, Chiras J, Simon JM, Rose M, Sola-Martinez T, Enkaoua E. Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology. 1996 Apr;199(1):241-7. doi: 10.1148/radiology.199.1.8633152.'}]}, 'descriptionModule': {'briefSummary': 'A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown that 8 Gy in a single fraction is very effective in providing pain relief, with complete or partial improvement in pain seen in 66% of patients with bone metastases. Percutaneous vertebroplasty (PV) is a technique designed to consolidate pathologic vertebral bodies through the injection of orthopaedic cement under fluoroscopic guidance. Consolidation provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis, haemangiomas, myeloma and metastatic diseases, with complete or partial improvement in pain seen in 70-85% of patients. To date, no randomized trial has tested the association of vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous spine metastases.\n\nA randomized trial has been designed to determine whether vertebroplasty and radiotherapy (8 Gy in a single fraction) provide enhancement pain and narcotic relief compared to radiotherapy alone for patients with painful osseous spine metastases', 'detailedDescription': 'Patients with 1 to 4 painful osseous spine metastases are randomized to 1 of 2 treatment arms:\n\n* Arm 1: 8 Gy in a single fraction\n* Arm 2: 8 Gy in a single fraction followed by vertebroplasty of the vertebral bodies, within 14 days after radiotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osseous spine metastases from squamous cell carcinoma or adenocarcinoma\n* One to four painful metastases located between the second cervical vertebra and the fifth lumbar vertebra\n* Moderate to severe pain\n* No spinal cord compression\n* Karnofsky performance status \\> 40\n\nExclusion Criteria:\n\n* Previous radiotherapy or surgery\n* Vertebral fracture or any other formal indication of stabilization of the rachis by surgery or vertebroplasty\n* Spinal cord compression\n* Known anomaly of the haemostasis, or needed anticoagulant treatment'}, 'identificationModule': {'nctId': 'NCT00267033', 'briefTitle': 'Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases', 'orgStudyIdInfo': {'id': 'P040426'}, 'secondaryIdInfos': [{'id': 'AOM04013'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'injection of orthopaedic cement into vertebral bodies', 'interventionNames': ['Procedure: injection of orthopaedic cement into vertebral bodies']}], 'interventions': [{'name': 'injection of orthopaedic cement into vertebral bodies', 'type': 'PROCEDURE', 'description': 'injection of orthopaedic cement into vertebral bodies', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'jean-Marc SIMON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Myriem CARRIER', 'oldOrganization': 'Department Clinical Research of Developpement'}}}}