Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-01-03 @ 7:23 PM
Study NCT ID:
NCT07291895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Radiotherapy for Palliation (Hi-D)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of accrual', 'timeFrame': 'From open to accrual to close to accrual (24 months)', 'description': '≥20 participants enrolled within 24 months from first patient accrued'}, {'measure': 'Feasibility of blinding', 'timeFrame': 'From enrollment to RT completion.', 'description': 'Trial Assignment Questionnaire administered post-treatment.'}], 'secondaryOutcomes': [{'measure': 'Compare changes in local control', 'timeFrame': 'From enrollment to end of study, accessed at 6 weeks, and month 3,12,18,24', 'description': 'Kaplan-Meier curves; stratified log-rank test'}, {'measure': 'Compare changes in OS', 'timeFrame': 'From enrollment to end of study at 24 months or death', 'description': 'Time from randomization to death from any cause. Kaplan-Meier; stratified log-rank.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastases', 'Palliative Radiotherapy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the feasibility of single-blind randomization between two palliative regimens - standard 24 Gray in 3 fractions vs a high-dose (Hi-D) 27 Gray in 3 fractions with dose escalation within the tumor in participants with bulky metastatic cancer.\n\nThe main question'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must meet all the following criteria to be eligible for participation in this study:\n* Age 18 or older.\n* Able to provide informed consent\n* Patient has histologically confirmed solid tumour malignancy\n* ECOG performance status 0 - 2\n* Life Expectancy \\> 6 months\n* 1-5 target lesions larger than 5cm\n* A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment\n* Not suitable for or declined curative-intent treatment\n* Subject has had a CT neck, chest, abdomen and pelvis or PET-CT within 8 weeks prior to enrollment, and with 12 weeks of treatment\n* MRI spine for patients receiving RT to vertebral or paraspinal metastases\n* Patient is judged able to:\n\n * Maintain a stable position during therapy\n * Tolerate immobilization device(s) that may be required to deliver radiation safely\n\nExclusion Criteria:\n\n* \\- Hematologic malignancy.\n* Disease limited to intracranial sites\n* Serious medical co-morbidities precluding radiotherapy\n* Bone metastases with no soft tissue component\n* Prior radiation to target lesion that precludes delivery of repeat radiation. All such cases should be discussed with the local and study PIs.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT07291895', 'briefTitle': 'High Dose Radiotherapy for Palliation (Hi-D)', 'organization': {'class': 'OTHER', 'fullName': 'British Columbia Cancer Agency'}, 'officialTitle': 'A Prospective Single-blinded Randomized Study of High Dose Radiotherapy for Palliation: Hi-D', 'orgStudyIdInfo': {'id': 'Hi-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Dose RT', 'description': '27Gy in 3 fractions with boost', 'interventionNames': ['Radiation: Palliative Radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Dose Palliative RT', 'description': '24Gy in 3 fractions', 'interventionNames': ['Radiation: Palliative Radiotherapy']}], 'interventions': [{'name': 'Palliative Radiotherapy', 'type': 'RADIATION', 'description': 'standard dose RT', 'armGroupLabels': ['Standard Dose Palliative RT']}, {'name': 'Palliative Radiotherapy', 'type': 'RADIATION', 'description': 'high-dose RT', 'armGroupLabels': ['High-Dose RT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'contacts': [{'name': 'Sandy Chang', 'role': 'CONTACT', 'email': 'sandy.chang@bccancer.bc.ca', 'phone': '6048776000'}], 'facility': 'BC Cancer - Vancouver', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Sandy Chang', 'role': 'CONTACT', 'email': 'sandy.chang@bccancer.bc.ca', 'phone': '6048776000'}], 'overallOfficials': [{'name': 'Wei Liu, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BC Cancer - Vancouver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}