Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-04-16 @ 4:34 PM
Study NCT ID:
NCT02407795
Status:
TERMINATED
Last Update Posted:
2022-05-13
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'very slow inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire', 'timeFrame': 'At six weeks since baseline', 'description': 'Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire'}], 'secondaryOutcomes': [{'measure': 'Comparison of time to pain response', 'timeFrame': 'pain response is calculated from the date of randomization at day 0-14, week 4, 6, and month 2, 3, 4, 6, 9, and 12', 'description': 'Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire'}, {'measure': 'Duration of pain relief', 'timeFrame': 'Pain relief is calculated from the date of randomization at day 0-14, week 4, 6, and month 2, 3, 4, 6, 9, and 12', 'description': 'Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'Quality of life is calculated from the date of randomization at day 0, 7, 14, week 4, 6, and month 2, 3, 4, 6, 9, and 12', 'description': 'EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires'}, {'measure': 'Toxicity measured by CTCAE 4.0 questionnaire', 'timeFrame': 'up to months 12', 'description': 'Toxicity measuredCTCAE 4.0 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stereotactic radiotherapy', 'pain reduction', 'quality of life'], 'conditions': ['Spinal Metastases']}, 'referencesModule': {'references': [{'pmid': '26829933', 'type': 'DERIVED', 'citation': 'Braam P, Lambin P, Bussink J. Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial. Trials. 2016 Feb 2;17:61. doi: 10.1186/s13063-016-1178-7.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.', 'detailedDescription': 'Study population: patients with painful spinal metastases from solid tumors without spinal cord compression or cord instability.\n\nObjective: This study will test the hypothesis that stereotactic radiotherapy gives a better and longer lasting reduction of pain, local control and therewith a better quality of life. This in order to optimize and to individualize the treatment options for the patient.\n\nStudy design: Complaints due to pain will be analysed using the validated Dutch Brief Pain Inventory (BPI) and side-effects will be recorded using the Common Toxicity Criteria for Adverse Events (CTCAE). In addition to this the quality of life will be analysed using the EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires. For analysis of cost-effectiveness the EQ-5D will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* solid tumor with radiological diagnosis of spinal metastases\n* pain score minimum 2 on 11-point scale\n* maximum of 2 consecutive or noncontiguous spinal vertebra involved by tumor at current level of interest\n* No or mild neurological signs (radiculopathy, dermatomal sensory change and muscle strength of involved extremity)\n* Karnofsky performance ≥60\n* WHO ≤2\n* life expectancy \\> 6 weeks\n* age ≥18\n* non-pregnant, non-lactating female patients\n\nExclusion Criteria:\n\n* history of previous radiotherapy to the spine at current level of interest\n* spinal instability or neurological deficit\n* pathological fracture or impending fracture needing fixation\n* prior surgery to the spine at current level of interest\n* clinical signs of spinal cord compression or severe neurological deficits\n* patients with a pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely\n* patients unable to undergo MRI\n* earlier nuclear medicine treatment\n* pregnancy\n* altered mental status that would prohibit the understanding and giving of informed consent'}, 'identificationModule': {'nctId': 'NCT02407795', 'acronym': 'RACOST', 'briefTitle': 'Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)', 'orgStudyIdInfo': {'id': 'NL45994.091.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'Conventional radiotherapy, 1x8Gy', 'interventionNames': ['Radiation: conventional radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Stereotactic radiotherapy, 1x20Gy', 'interventionNames': ['Radiation: stereotactic radiotherapy']}], 'interventions': [{'name': 'conventional radiotherapy', 'type': 'RADIATION', 'description': '1x8Gy', 'armGroupLabels': ['Arm 1']}, {'name': 'stereotactic radiotherapy', 'type': 'RADIATION', 'description': '1x20Gy or equivalent dose fractionation schedule', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6815 AD', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Radiotherapiegroep Arnhem', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '7416 SE', 'city': 'Deventer', 'country': 'Netherlands', 'facility': 'Radiotherapiegroep Deventer', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'zip': '6229 ET', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'MAASTRO clinic', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboudumc Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Medisch Centrum Haaglanden', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '8025 AB', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'P Braam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboudumc Nijmegen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Koningin Wilhelmina Fonds', 'class': 'OTHER'}, {'name': 'Maastro Clinic, The Netherlands', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}