Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-30 @ 1:25 AM
Study NCT ID:
NCT00974168
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2009-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Cord Compression Re-Treat Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D013117', 'term': 'Spinal Cord Compression'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-26', 'studyFirstSubmitDate': '2009-09-09', 'studyFirstSubmitQcDate': '2009-09-09', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to treatment as assessed by mobility via the Tomita mobility scale', 'timeFrame': '5 weeks after completion of radiation therapy'}, {'measure': 'Overall response rate (stabilization and response) (stage I)', 'timeFrame': '5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter'}], 'secondaryOutcomes': [{'measure': 'Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system', 'timeFrame': '5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter'}, {'measure': 'Toxicity other than spine (acute toxicity assessed at weeks 1 and 5 and late toxicity assessed at 3 months and at subsequent follow-ups) evaluated according to RTOG criteria', 'timeFrame': '5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter'}, {'measure': 'Pain control via the pain visual analogue score', 'timeFrame': '5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter'}, {'measure': 'Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire', 'timeFrame': '5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter'}, {'measure': 'Median survival (time from the date of recruitment/treatment to death)', 'timeFrame': 'Until death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain', 'radiation toxicity', 'spinal cord compression', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Pain', 'Radiation Toxicity', 'Spinal Cord Compression', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '36482188', 'type': 'DERIVED', 'citation': 'Wallace ND, Dunne MT, McArdle O, Small C, Parker I, Shannon AM, Clayton-Lea A, Parker M, Collins CD, Armstrong JG, Gillham C, Coffey J, Fitzpatrick D, Salib O, Moriarty M, Stevenson MR, Alvarez-Iglesias A, McCague M, Thirion PG. Efficacy and toxicity of primary re-irradiation for malignant spinal cord compression based on radiobiological modelling: a phase II clinical trial. Br J Cancer. 2023 Feb;128(4):576-585. doi: 10.1038/s41416-022-02078-w. Epub 2022 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may be effective in treating malignant spinal cord compression in patients who have received previous radiation therapy to the spine.\n\nPURPOSE: This phase II trial is studying radiation therapy in treating patients with malignant spinal cord compression.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine the efficacy of a biologically effective dose-based re-irradiation strategy, in terms of the response rate (based on the mobility score using the Tomita scale where improvement in mobility or stable mobility score will be regarded as a response) in patients with malignant spinal cord compression.\n\nSecondary\n\n* To determine quality of life as assessed by the EORTC QLQ-C15 PAL version 1.0 questionnaire.\n* To determine the non-spinal radiation-induced toxicity using standard RTOG criteria.\n* To determine the rate of long-term spinal toxicity and radiation-induced myelopathy using the RTOG SOMA morbidity grading system.\n\nOUTLINE: Patients are divided into 2 groups according to the interval since their most recent radiotherapy to the involved area of the spinal cord.\n\n* Group 1 (\\< 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative biologically effective dose (BED) ≤ 100 Gy\\_2 in addition to receiving other current treatment.\n* Group 2 (≥ 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative BED ≤ 130 Gy\\_2 in addition to receiving other current treatment.\n\nMobility score is assessed and patients complete a quality-of-life assessment at baseline and at each follow-up visit starting at week 5.\n\nAfter completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* MRI-confirmed diagnosis of malignant spinal cord compression\n\n * MRI of the entire spine performed\n* Histologically proven malignancy\n\n * No primary tumors of the spine or vertebral column\n* Undergone previous radiotherapy to the involved area of the spinal cord (e.g., full segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated)\n\n * Maximum biologically effective dose received from previous irradiation ≤ 90 Gy\\_2\n* Deemed not suitable for neurosurgical intervention at the time of initial assessment\n\n * Patients deemed inoperable are eligible\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 40-100%\n* Short life expectancy\n* No medical or psychiatric condition that, in the opinion of the investigator or research team, contraindicates participation in this study\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00974168', 'briefTitle': 'Spinal Cord Compression Re-Treat Study', 'nctIdAliases': ['NCT00624507'], 'organization': {'class': 'NETWORK', 'fullName': 'Cancer Trials Ireland'}, 'officialTitle': 'A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression', 'orgStudyIdInfo': {'id': 'CTRIAL-IE (ICORG) 07-11'}, 'secondaryIdInfos': [{'id': 'ICORG 07-11'}, {'id': 'EU-20953'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Radiation Cumulative BED ≤ 100 Gy2', 'interventionNames': ['Radiation: Cumulative BED ≤ 100']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Cumulative BED ≤ 130 Gy2', 'interventionNames': ['Radiation: Cumulative BED ≤ 130 Gy2']}], 'interventions': [{'name': 'Cumulative BED ≤ 100', 'type': 'RADIATION', 'description': 'Radiation', 'armGroupLabels': ['A']}, {'name': 'Cumulative BED ≤ 130 Gy2', 'type': 'RADIATION', 'description': 'Radiation', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6', 'city': 'Dublin', 'country': 'Ireland', 'facility': "Saint Luke's Radiation Oncology Network", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospital', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}], 'overallOfficials': [{'name': 'Pierre Thirion, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Saint Luke's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Trials Ireland', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}