Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT03747133
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2018-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SABR for Renal Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2018-11-01', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the radiation induced renal impairments in patients receiving SABR.', 'timeFrame': '2 years', 'description': 'The prevalence of nephron toxicity in patients treated with SABR, measured by the change in Glomerular Filtration Rate (GFR) every 4 months over 2 years.'}], 'secondaryOutcomes': [{'measure': 'Chronic Kidney Disease Stage Progression', 'timeFrame': '2 years', 'description': 'Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines'}, {'measure': '2-year Local recurrence rate', 'timeFrame': '2 years', 'description': '2 year local recurrence rate of kidney tumors treated with SABR, measured by assessing the change of irradiated kidney function on functional imaging.'}, {'measure': 'Patient Reported Outcomes', 'timeFrame': '2 years', 'description': 'The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire.'}, {'measure': 'Incidence of acute and late toxicities', 'timeFrame': '2 years', 'description': 'The incidence of acute (≤3 months) and late complication of interest (GI or GU complications, high blood pressure and adrenal insufficiency) as assessed by CTCAE version 5.0.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stereotactic Body Radiation Therapy', 'SABR', 'Radiation Therapy', 'Renal Cell Carcinoma', 'RCC'], 'conditions': ['Renal Tumor']}, 'referencesModule': {'references': [{'pmid': '41290048', 'type': 'DERIVED', 'citation': 'Glicksman RM, Winter J, McPartlin A, Santiago AT, Wang K, Bernstein J, Dang J, Tsui G, Chung P, Mesci A, Gutierrez E, Raman S, Berlin A, Catton C, Bayley A, Warde P, Krishna S, Finelli A, Hamilton RJ, Pace KT, Kitchlu A, Helou J. Stereotactic body radiotherapy for renal tumors: a prospective phase 2 clinical trial. Int J Radiat Oncol Biol Phys. 2025 Nov 23:S0360-3016(25)06480-6. doi: 10.1016/j.ijrobp.2025.11.005. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm\n* Histological or radiological diagnosis of renal tumor\n* Inoperable: High risk for surgery or declined surgery\n* ECOG performance status of 0-3\n\nExclusion Criteria:\n\n* ≥5 active metastases\n* Sysstemic therapy (except endocrine therapy) wthin 6 days prior to SABR\n* Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney\n* Patients with end stage renal failure \\> 4(KDOQI guidelines)\n* Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis'}, 'identificationModule': {'nctId': 'NCT03747133', 'briefTitle': 'SABR for Renal Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors', 'orgStudyIdInfo': {'id': '18-5481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stereotactic Ablative Radiotherapy', 'description': 'Adult patients with Kidney mass (either primary or metastasis) amenable to SABR', 'interventionNames': ['Radiation: Stereotactic Ablative Radiotherapy']}], 'interventions': [{'name': 'Stereotactic Ablative Radiotherapy', 'type': 'RADIATION', 'description': 'Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.', 'armGroupLabels': ['Stereotactic Ablative Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L4M 6M2', 'city': 'Barrie', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': 'Royal Victoria Regional Health Centre', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Andrew McPartlin, MD', 'role': 'CONTACT', 'email': 'andrew.mcpartlin@rmp.uhn.ca', 'phone': '416-946-4501', 'phoneExt': '4855'}, {'name': 'Andrew McPartlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrew Bayley, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Health Network - Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Andrew McPartlin, MD', 'role': 'CONTACT', 'email': 'andrew.mcpartlin@rmp.uhn.ca', 'phone': '416-946-4501', 'phoneExt': '4855'}], 'overallOfficials': [{'name': 'Andrew McPartlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Princess Margaret Cancer Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}