Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-31 @ 4:14 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:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
Official Title:
Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARE
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRB00427823 | OTHER | JHM IRB | View |