Proton therapy for kidney cancer treatment
Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)
This study is testing if proton therapy can help people with kidney cancer who can't have surgery by improving their treatment outcomes while protecting their healthy kidney tissue.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06376669 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of proton-based stereotactic body radiation therapy (SBRT) on kidney function and various oncologic outcomes in patients with primary renal cell carcinoma (RCC). It focuses on patients who are not candidates for surgical intervention due to medical comorbidities or technical limitations. The study aims to determine if proton therapy can improve local control and survival rates while minimizing damage to healthy kidney tissue compared to conventional x-ray SBRT. By utilizing the unique properties of proton therapy, the study seeks to enhance treatment efficacy while preserving kidney function.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven renal cell carcinoma who are not suitable for surgery or local ablative procedures.
Not a fit: Patients with metastatic disease or those who have previously received radiation treatment in overlapping fields may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer treatment option for patients with renal cell carcinoma, preserving kidney function while effectively controlling cancer.
How similar studies have performed: Previous studies using conventional x-ray SBRT have shown improved outcomes for RCC, suggesting that this novel approach with proton therapy may also be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Biopsy proven renal cell carcinoma. 3. No clinical or radiographic evidence of metastatic disease. 4. Not a candidate for surgical treatment or local ablative procedures. 5. Subjects are able to undergo either an MRI or administration of contrast agent for CT. Exclusion Criteria: 1. Prior history of radiation treatment with overlapping fields. 2. Patients with proven metastatic disease. 3. Female subjects who are pregnant or planning to become pregnant during the treatment.
Where this trial is running
Washington D.C., District of Columbia
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Sherif Shaaban, MD — Johns Hopkins University
- Study coordinator: Sherif Shaaban
- Email: sshaaba1@jhmi.edu
- Phone: 202-919-2523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.