Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT01429493
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2011-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2011-09-02', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of pain response 1 month after radiotherapy', 'timeFrame': '1 month after radiotherapy', 'description': 'Pain is measured with the visual analogue scale. Response is scored in accordance to the guidelines of the international consensus on palliative radiotherapy.'}], 'secondaryOutcomes': [{'measure': 'Quality of life 1 month after radiotherapy.', 'timeFrame': '1 Month after radiotherapy', 'description': 'Quality of life 1 month after radiotherapy measured with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Bone Metastases Module (QLQ-BM22).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bone Metastases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. It is postulated that the clinical target volume (CTV) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. These findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. The hypothesis is that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. The primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Painful bone metastasis of solid tumors\n* Pain score minimum of 2 on a scale of 10\n* A maximum number of painful bone metastases: 3 or more\n* Life expectancy \\> 3 months\n* Age minimum 18 years old\n* Signed informed consent\n\nExclusion Criteria:\n\n* Tumor histology (renal cell and melanoma vs. other solid tumors)\n* VAS pain score (\\<5 vs. 6-10).\n* Bisphosphonate use (yes vs. no)\n* Opioid analgesics (yes vs. no)\n* Corticosteroid use (yes vs. no)\n* Spine vs non-spine localisation'}, 'identificationModule': {'nctId': 'NCT01429493', 'briefTitle': 'Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial', 'orgStudyIdInfo': {'id': '2011/541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional radiotherapy', 'interventionNames': ['Radiation: Conventional Radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Biological image-guided radiotherapy with conventional dose.', 'interventionNames': ['Radiation: Biological image-guided radiotherapy with conventional dose.']}, {'type': 'EXPERIMENTAL', 'label': 'Biological image-guided SBRT with dose-escalation.', 'interventionNames': ['Radiation: Biological image-guided SBRT with dose-escalation.']}], 'interventions': [{'name': 'Conventional Radiotherapy', 'type': 'RADIATION', 'description': 'Conventional radiotherapy will be used (8 Gy/ 1 fraction).', 'armGroupLabels': ['Conventional radiotherapy']}, {'name': 'Biological image-guided radiotherapy with conventional dose.', 'type': 'RADIATION', 'description': 'Biological image-guided radiotherapy on the positron emitting tomography (PET) positive lesion with conventional dose (8Gy/ 1 fraction) will be used.', 'armGroupLabels': ['Biological image-guided radiotherapy with conventional dose.']}, {'name': 'Biological image-guided SBRT with dose-escalation.', 'type': 'RADIATION', 'description': 'Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used.', 'armGroupLabels': ['Biological image-guided SBRT with dose-escalation.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Wilfried De Neve, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}