Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

— SPARE  

Official title:

Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376669
• Other study ID #: J2421
• Secondary ID: IRB00427823
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: August 2030

Study information

• Verified date: April 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Sherif Shaaban
• Phone: 202-919-2523
• Email: sshaaba1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2030
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Radiation:
• Proton Stereotactic Body Radiation therapy (SBRT)
Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of PROTON-BASED SBRT treatment Adverse Events	Adverse events associated with PROTON-BASED SBRT treatment.	24 months post treatment
Secondary	Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions	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).	Baseline and every 3-6 months up to 2 years post treatment
Secondary	Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions	Systemic progression is defined as appearance of new lesions outside the radiation field (away from the primary tumor).	Baseline and every 3-6 months up to 2 years post treatment
Secondary	Time to locoregional progression	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.	Baseline and every 3-6 months up to 2 years post treatment
Secondary	Overall survival	Overall survival (OS) is defined as the duration of time from start of treatment to the time of death from any cause.	24 months post treatment