Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-03-03 @ 12:45 AM
Study NCT ID:
NCT00193869
Status:
COMPLETED
Last Update Posted:
2007-05-10
First Post:
2005-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-08', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2007-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfactory recruitment', 'timeFrame': 'Failure to accrue 30 patients in 15 months will initiate early closure of this study.'}, {'measure': 'Acceptable steroid toxicity rate at 28 days with reference to baseline.', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Ambulation rates at 1 month', 'timeFrame': '1 month'}, {'measure': 'Barthel Index', 'timeFrame': 'Final analysis when all patients have been followed for 1 month'}, {'measure': 'Functional Independence (FIM)', 'timeFrame': 'Final analysis when all patients have been followed for 1 month'}, {'measure': 'Functional Improvement Score (FIS)within 2 weeks with reference to baseline', 'timeFrame': '2 weeks'}, {'measure': 'Pain', 'timeFrame': 'Final analysis when all patients have been followed for 1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radiotherapy', 'Dose fractionation'], 'conditions': ['Spinal Cord Compression From Neoplasm Metastasis']}, 'referencesModule': {'references': [{'pmid': '16477923', 'type': 'RESULT', 'citation': 'Graham PH, Capp A, Delaney G, Goozee G, Hickey B, Turner S, Browne L, Milross C, Wirth A. A pilot randomised comparison of dexamethasone 96 mg vs 16 mg per day for malignant spinal-cord compression treated by radiotherapy: TROG 01.05 Superdex study. Clin Oncol (R Coll Radiol). 2006 Feb;18(1):70-6. doi: 10.1016/j.clon.2005.08.015.'}], 'seeAlsoLinks': [{'url': 'http://www.trog.com.au', 'label': 'Click here for more information about this study on the TROG official website'}]}, 'descriptionModule': {'briefSummary': 'The study aimed to pilot the viability of a full scale randomised comparison of 2 steroid doses in malignant spinal cord compression, to establish safety of high dose dexamethasone in this setting in Australia, to test web registration and randomisation and to compare different functional outcome measures.', 'detailedDescription': 'Malignant spinal cord compression (MSCC) is an uncommon condition with an estimated annual incidence of 2.5 per 100,000. It is a dreaded complication of malignancy because of the severe impact paralysis and sphincter disturbance has on quality and duration of survival.\n\nRat models have demonstrated the effectiveness of high doses of steroids. Only three randomised controlled trials (RCTs) have been published. The first compared radiotherapy to laminectomy plus radiotherapy in a series of 29 patients and failed to show any significant differences The widespread commonly used dose of Dexamethasone in Australia at that time was 16 mg/24 hr and the main concern for implementing higher doses was the toxicity profile reported in the few small randomised comparisons available at the time.In view of the conflict between standard Australian practice versus published (overseas) guidelines, a randomised comparison was proposed in Australia. This study was a pilot study initiated to determine the viability of a large trial, to pilot the use of web technology for trial conduct and to determine clinically useful outcome measures apart from simple ambulation rates.\n\nComparisons: Patients randomised to receive either 16mg/24hr or 96mg/24hr dexamethasone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malignant spinal cord compression with at least one of pain, weakness, sensory disturbance or sphincter disturbance\n* Histology not required if prior biopsy proven malignancy\n* Any stage\n* Age \\>16 years\n* ECOG 1-3 prior to cord compression event\n* Minimum power 1 of 5 point scale Must not be paraplegic\n* Minimum expected survival 2 months\n* Relevant minimum lab values\n* Patients capable of childbearing using adequate contraception\n* Written informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to within vertebral±one level affected by cord compression\n* Prior treatment for spinal cord compression at the current level\n* Histology is lymphoma or myeloma\n* Power less than 1 of 5\n* More than 12 hours after initiation of dexamethasone\\>4mg/24hr\n* Pre-existing co-morbid conditions - peptic ulceration or cardiac failure\n* Allergy to study medications\n* Multilevel cord compression or meningeal carcinomatosis\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT00193869', 'briefTitle': 'SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).', 'organization': {'class': 'OTHER', 'fullName': 'Trans Tasman Radiation Oncology Group'}, 'officialTitle': 'A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy', 'orgStudyIdInfo': {'id': 'TROG 01.05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Hospital', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}], 'overallOfficials': [{'name': 'Peter Graham, FRANZCR', 'role': 'STUDY_CHAIR', 'affiliation': 'St George Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trans Tasman Radiation Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Council New South Wales', 'class': 'OTHER'}]}}}