Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma
SPARE
Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)
2 other identifiers
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2025
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedStudy Start
First participant enrolled
February 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
March 26, 2025
March 1, 2025
2.3 years
April 16, 2024
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels
Change in serum creatine levels from Baseline visit.
Baseline and every 3-6 months up to 2 years post treatment
Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values
Change in eGFR values from Baseline visit.
Baseline and every 3-6 months up to 2 years post treatment
Secondary Outcomes (5)
Number of PROTON-BASED SBRT treatment Adverse Events
24 months post treatment
Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions
Baseline and every 3-6 months up to 2 years post treatment
Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions
Baseline and every 3-6 months up to 2 years post treatment
Time to locoregional progression
Baseline and every 3-6 months up to 2 years post treatment
Overall survival
24 months post treatment
Study Arms (1)
Proton Stereotactic Body Radiation Therapy (SBRT)
EXPERIMENTALThe SBRT group is the single arm of this study.
Interventions
Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Biopsy proven renal cell carcinoma.
- No clinical or radiographic evidence of metastatic disease.
- Not a candidate for surgical treatment or local ablative procedures.
- Subjects are able to undergo either an MRI or administration of contrast agent for CT.
You may not qualify if:
- Prior history of radiation treatment with overlapping fields.
- Patients with proven metastatic disease.
- Female subjects who are pregnant or planning to become pregnant during the treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sherif Shaaban, MD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2024
First Posted
April 19, 2024
Study Start
February 25, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
August 1, 2030
Last Updated
March 26, 2025
Record last verified: 2025-03