Clinical trial NCT06376669: Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma
Official title: Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: Stereotactic Body Radiation Therapy
SBRT
RCC
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Robert L. Sloan Fund for Cancer Research
First posted: 2024-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
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
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
Secondary outcomes:
measure: Number of PROTON-BASED SBRT treatment Adverse Events
timeFrame: 24 months post 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
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
measure: Time to locoregional progression
timeFrame: Baseline and every 3-6 months up to 2 years post treatment
measure: Overall survival
timeFrame: 24 months post treatment
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
Study officials:
affiliation: Johns Hopkins University
name: Sherif Shaaban, MD
role: PRINCIPAL_INVESTIGATOR
References: