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Trial Title:
Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma
NCT ID:
NCT06376669
Condition:
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
Stereotactic Body Radiation Therapy
SBRT
RCC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Proton Stereotactic Body Radiation therapy (SBRT)
Description:
Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks
Arm group label:
Proton Stereotactic Body Radiation Therapy (SBRT)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 2024
Completion date:
August 2030
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
Robert L. Sloan Fund for Cancer Research
Agency class:
Other
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06376669
