Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-29 @ 10:24 AM
Study NCT ID:
NCT05817604
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local relapse-free survival', 'timeFrame': 'Participants should be followed continuously during 5 years', 'description': 'Local Control assessed by RECISTv1.1 criteria with TC, MRI or PET-scan'}], 'secondaryOutcomes': [{'measure': 'Metastases-Free Survival', 'timeFrame': 'Participants should be followed continuously during 5 years', 'description': 'Metastases-Free Survival assessed by RECISTv1.1 criteria with TC, MRI or PET-scan'}, {'measure': 'Overall Survival', 'timeFrame': 'Participants should be followed continuously during 5 years', 'description': 'Defined as the time from diagnose to the date of death from any cause.'}, {'measure': 'Cancer Specific Survival', 'timeFrame': 'Participants should be followed continuously during 5 years', 'description': 'Defined as the time from diagnose to the date of death from renal cancer.'}, {'measure': 'Renal treatment-related adverse events', 'timeFrame': 'Participants should be followed continuously during 5 years', 'description': 'Specific Renal Function-related adverse events measured by estimate Glomerular Filtration Rate'}, {'measure': 'Non-Renal treatment-related adverse events', 'timeFrame': 'Participants should be followed continuously during 5 years', 'description': 'Number of patients with Non-Renal treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v5.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stereotactic Body Radiotherapy', 'Renal Cancer', 'Primary Localized Renal Cancer', 'Kidney Neoplasm', 'Radiotherapy', 'Inoperable Cancer', 'Stereotactic ablative radiotherapy', 'SBRT', 'SABR'], 'conditions': ['Kidney Neoplasm', 'Renal Cancer', 'Inoperable Disease', 'SBRT', 'SABR']}, 'descriptionModule': {'briefSummary': 'Study evaluating the activity and efficacy of Stereotactic Body Radiotherapy for the treatment of medically inoperable localized renal cancer', 'detailedDescription': 'Stereotactic Body Radiotherapy (SBRT) is a non-invasive alternative to surgery to control localized primary renal cell cancer (RCC) in medically inoperable patients. The kidney tumor has classically been considered radioresistant. Multiple retrospective series and few Phase II trial have studied the role of SBRT in localized renal tumors with favorable outcomes. Although large prospective studies are lacking, we evaluate the safety and effectiveness of SBRT for the treatment of renal cancer.\n\nParticipants will be allocated to recieve either single 26Gy fraction or Multifraction 3 - 5 fraction-squeme.\n\nAssesment at regular intervals will estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.\n\nFollow-up visits occur at 1month and every 3 months in the first year after SBRT, then every 6 months in the second year and then yearly until study closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with localized renal cancer selected by each tumor board from Consorci Sanitari de Terrassa (CST) collaborative group medical centers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of Renal tumor and/or highly suspected malignant neoplasm by CT, MRI or PET.\n* Tumor Diameter \\>1cm - \\<7cm\n* Tumor visible on CT planning\n* Medically inoperable disease (or rejection of surgery)\n* Karnofsky Index \\>70%\n* \\>18 y.o.\n* Informed Consent signature\n\nExclusion criteria:\n\n* Non-oncological renal disease or autoinmunological disorder that does not recommend the treatment with radiotherapy.\n* Previous local/regional RT\n* Life expectancy \\<6 months\n* Concomitance with other antineoplastic drugs'}, 'identificationModule': {'nctId': 'NCT05817604', 'acronym': 'SABINA', 'briefTitle': 'Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)', 'orgStudyIdInfo': {'id': 'SABINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Localized Renal Cancer-One arm', 'description': 'Patients diagnosed with medically inoperable localized renal cancer \\[Size \\<7cm (cT1b)\\] based on TC, MRI or PET Image Study.', 'interventionNames': ['Radiation: SBRT']}], 'interventions': [{'name': 'SBRT', 'type': 'RADIATION', 'description': 'Tumors ≤ 4cm: Single SBRT 26Gy dose or Multifraction SBRT dose 14Gyx3 fraction-squeme.\n\nTumors ≥ 4cm: Multifraction SBRT dose 14Gyx3 or 9Gyx5 fraction-squeme.', 'armGroupLabels': ['Localized Renal Cancer-One arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'Manuel Galdeano-Rubio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consorci Sanitari de Terrassa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist, MD, MSc', 'investigatorFullName': 'Manuel Galdeano-Rubio', 'investigatorAffiliation': 'Consorci Sanitari de Terrassa'}}}}