Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-04 @ 3:22 AM
Study NCT ID:
NCT06376669
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2024-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels', 'timeFrame': 'Baseline and every 3-6 months up to 2 years post treatment', 'description': 'Change in serum creatine levels from Baseline visit.'}, {'measure': 'Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values', 'timeFrame': 'Baseline and every 3-6 months up to 2 years post treatment', 'description': 'Change in eGFR values from Baseline visit.'}], 'secondaryOutcomes': [{'measure': 'Number of PROTON-BASED SBRT treatment Adverse Events', 'timeFrame': '24 months post treatment', 'description': 'Adverse events associated with PROTON-BASED SBRT treatment.'}, {'measure': 'Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions', 'timeFrame': 'Baseline and every 3-6 months up to 2 years post treatment', 'description': 'Local progression is defined as an increased size of the primary lesion or appearance of a new lesion in the kidney (within the radiation field).'}, {'measure': 'Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions', 'timeFrame': 'Baseline and every 3-6 months up to 2 years post treatment', 'description': 'Systemic progression is defined as appearance of new lesions outside the radiation field (away from the primary tumor).'}, {'measure': 'Time to locoregional progression', 'timeFrame': 'Baseline and every 3-6 months up to 2 years post treatment', 'description': 'Time to locoregional progression is defined as time from the date of first SBRT PROTON-BASED SBRT fraction to date of locoregional progression, according to RECIST v1.1 criteria.'}, {'measure': 'Overall survival', 'timeFrame': '24 months post treatment', 'description': 'Overall survival (OS) is defined as the duration of time from start of treatment to the time of death from any cause.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stereotactic Body Radiation Therapy', 'SBRT', 'RCC'], 'conditions': ['Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival.', 'detailedDescription': 'The incidence of kidney cancer diagnosis has been increasing over the last years. Surgical resection represents the mainstay treatment. However, many patients are deemed unfit for surgery due to medical comorbidities or technical limitations. There are non-surgical options including active surveillance, cryotherapy, microwave ablation, radiofrequency and stereotactic radiation therapy (SBRT). SBRT using conventional x-rays has recently been shown to improve outcomes for patients with primary renal cell carcinoma (RCC) in terms of local control and toxicity. However, this treatment was associated with a significant decline in kidney function that necessitates additional intervention including dialysis in some patients. Proton therapy represents an emerging technique with unique properties that allow the bulk of the proton cancer fighting energy to be released at the tumor (Bragg peak) while sparing nearby healthy tissues and organs, particularly the remaining healthy kidney, ipsilateral kidney, bowels, spine and liver. With this technology, both kidneys, the remaining ipsilateral and contralateral, could be spared and thus less damage is expected. This study aims to study the impact of proton based SBRT on the kidney function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Biopsy proven renal cell carcinoma.\n3. No clinical or radiographic evidence of metastatic disease.\n4. Not a candidate for surgical treatment or local ablative procedures.\n5. Subjects are able to undergo either an MRI or administration of contrast agent for CT.\n\nExclusion Criteria:\n\n1. Prior history of radiation treatment with overlapping fields.\n2. Patients with proven metastatic disease.\n3. Female subjects who are pregnant or planning to become pregnant during the treatment.'}, 'identificationModule': {'nctId': 'NCT06376669', 'acronym': 'SPARE', 'briefTitle': 'Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)', 'orgStudyIdInfo': {'id': 'J2421'}, 'secondaryIdInfos': [{'id': 'IRB00427823', 'type': 'OTHER', 'domain': 'JHM IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proton Stereotactic Body Radiation Therapy (SBRT)', 'description': 'The SBRT group is the single arm of this study.', 'interventionNames': ['Radiation: Proton Stereotactic Body Radiation therapy (SBRT)']}], 'interventions': [{'name': 'Proton Stereotactic Body Radiation therapy (SBRT)', 'type': 'RADIATION', 'description': 'Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks', 'armGroupLabels': ['Proton Stereotactic Body Radiation Therapy (SBRT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sherif Shaaban', 'role': 'CONTACT', 'email': 'sshaaba1@jhmi.edu', 'phone': '202-919-2523'}], 'facility': 'Sibley Memorial Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Sherif Shaaban', 'role': 'CONTACT', 'email': 'sshaaba1@jhmi.edu', 'phone': '202-919-2523'}, {'name': 'Ryan Manuel', 'role': 'CONTACT', 'email': 'rmanuel5@jhmi.edu', 'phone': '410-955-4261'}], 'overallOfficials': [{'name': 'Sherif Shaaban, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert L. Sloan Fund for Cancer Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}