SABR for Kidney Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Investigational agents

Disqualifiers: Brain metastasis, Prior systemic therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of radiation treatment called stereotactic ablative body radiation (SABR) for individuals with kidney cancer that has spread to a few locations outside the brain. The main goal is to determine if SABR can delay the need for more intense treatments and extend the time patients live without cancer progression. The trial also examines overall survival, cancer-specific survival, control of treated cancer spots, and quality of life. Suitable candidates have kidney cancer with up to three areas of spread, confirmed by scans, and have not received certain treatments for kidney cancer in the past year. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have received systemic therapy for kidney cancer in the past year, except for one line of immuno- or cytokine therapy, you may not be eligible to participate.

Is there any evidence suggesting that stereotactic ablative body radiation (SAbR) is likely to be safe for humans?

Research has shown that Stereotactic Ablative Body Radiation (SABR) is generally safe for people with kidney cancer. One study found that SABR was effective and safe over the long term for treating primary renal cell carcinoma, a type of kidney cancer. Patients who received SABR experienced low rates of serious side effects over five years.

In another study, patients tolerated SABR well, with few reports of severe side effects. This suggests that SABR can safely target cancer cells while minimizing harm to nearby healthy tissue. Overall, these findings support the safety of SABR in treating kidney cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic ablative body radiation (SABR) is unique because it offers a precise, high-dose radiation treatment that targets kidney cancer metastases with pinpoint accuracy. Traditional treatments for metastatic kidney cancer often involve systemic therapies like immunotherapy or targeted therapy, which affect the whole body. SABR, on the other hand, focuses directly on the cancerous sites, potentially sparing healthy tissue and reducing side effects. Researchers are excited about SABR because it can treat metastases in a highly targeted way, possibly leading to better outcomes and fewer complications compared to conventional treatments.

What evidence suggests that SAbR might be an effective treatment for kidney cancer?

Research has shown that stereotactic ablative body radiation (SABR) is highly effective for kidney cancer. In one study, 81 patients with kidney cancer received SABR, and 98% experienced no cancer growth in the treated area for two years, indicating that the cancer did not return in almost all patients. Another study found that SABR is effective for various types of kidney cancer. Long-term follow-ups have demonstrated that SABR is safe and effective, with a low likelihood of cancer recurrence in the treated area. These findings suggest that SABR could be a promising option for managing the spread of kidney cancer. Participants in this trial will receive SABR to all sites of measurable metastases, with new sites evaluated for continued treatment if deemed appropriate by medical and radiation oncologists. ^{1 2 4 6 7}

Who Is on the Research Team?

Raquibul Hannan, MD, PhD

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for adults with kidney cancer that has spread to up to three other body parts, but not the brain. They must have had a recent scan showing this and can't have had certain treatments in the last year. Women who can get pregnant and men must use birth control during and after treatment.

Inclusion Criteria

My scans show cancer has spread and were done within the last month.

I have had surgery or radiation before.

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and for 90 days after Radiation treatment has been completed. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Exclusion Criteria

I have brain metastasis confirmed by MRI or CT scans.

I have had only one immuno- or cytokine therapy for kidney cancer in the last year.

Subjects receiving any other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive Stereotactic Ablative Body Radiation (SAbR) to all sites of measurable metastases

6-8 weeks

Weekly visits for radiation sessions

Follow-up

Participants are monitored for safety and effectiveness after radiation treatment

6 years

Follow-up visits every 12 weeks for the first year, then every 26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic ablative body radiation (SABR)

Trial Overview The study tests if Stereotactic Ablative Body Radiation (SAbR) can delay the need for systemic therapy by targeting only a few metastatic spots in kidney cancer patients, potentially improving survival without immediately resorting to drugs affecting the whole body.

How Is the Trial Designed?

Group I: Stereotactic ablative body radiation (SABR) Experimental Treatment 1 Intervention

Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

High-dose stereotactic ablative body radiotherapy (SABR) for oligometastatic renal cell carcinoma (RCC) showed promising efficacy, with median progression-free survival (PFS) of 11.3 months and overall survival (OS) of 29.7 months in a study of 35 patients.

Early intervention with SABR, particularly before the failure of tyrosine kinase inhibitors (TKIs), was associated with significant survival benefits, suggesting that timely treatment may enhance outcomes for patients with oligometastatic RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of High-Dose Stereotactic Ablative Radiotherapy to All/Multiple Sites for Oligometastatic Renal Cell Cancer Patients. Ma, MW., Li, HZ., Gao, XS., et al.[2023]

Stereotactic ablative body radiotherapy (SABR) has been shown to be an effective long-term treatment for primary renal cell carcinoma, with a low local failure rate of 5.5% at 5 years among 190 patients studied across multiple countries.

The study found that single-fraction SABR resulted in fewer local failures compared to multifraction SABR, and importantly, there were no severe treatment-related side effects or deaths, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data meta-analysis from IROCK (the International Radiosurgery Consortium of the Kidney). Siva, S., Ali, M., Correa, RJM., et al.[2023]

Stereotactic ablative body radiotherapy (SABR) has shown a local control rate of over 90% in treating primary renal cell carcinoma (RCC) across 589 cases, with low rates of severe toxicity (grade 3-4) ranging from 0-9%.

In patients with oligometastatic RCC, SABR can delay the need for systemic therapy for at least one year in 70-90% of cases, indicating its effectiveness as a treatment option and its compatibility with systemic therapies like targeted therapy or immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. Ali, M., Mooi, J., Lawrentschuk, N., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is a well-tolerated and effective treatment for primary renal cell carcinoma, showing high rates of local control (97.8%) and cancer-specific survival (95.7%) at 2 years among 223 patients studied across multiple institutions.

Patients receiving single-fraction SABR had better progression-free survival and cancer-specific survival compared to those receiving multifraction SABR, suggesting that single-fraction treatment may be more beneficial for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled analysis of stereotactic ablative radiotherapy for primary renal cell carcinoma: A report from the International Radiosurgery Oncology Consortium for Kidney (IROCK). Siva, S., Louie, AV., Warner, A., et al.[2022]

In a study of 62 kidney cancer patients treated with stereotactic ablative body radiotherapy (SABR), eliminating respiratory motion significantly reduced the dose received by the healthy kidney, with a reduction of 12 cc of kidney volume receiving 50% of the prescription dose for each centimeter of tumor motion amplitude.

The study also found that removing respiratory motion improved estimated renal function, with a gain of 4.4% in glomerular filtration rate (GFR) for each centimeter of motion eliminated, indicating a potential benefit for kidney health during SABR treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the impact on renal function of kidney SABR through management of respiratory motion. Gaudreault, M., Siva, S., Kron, T., et al.[2021]

Stereotactic ablative body radiotherapy (SABR) for renal cell carcinoma (RCC) in inoperable patients was found to be feasible and well tolerated, with 89% of patients completing the treatment without severe side effects.

At a median follow-up of 24 months, SABR demonstrated excellent cancer control with 100% freedom from local progression and a 92% overall survival rate, although there was a significant decrease in kidney function over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy for inoperable primary kidney cancer: a prospective clinical trial. Siva, S., Pham, D., Kron, T., et al.[2022]

In a study of 16 patients with renal cell carcinoma treated with stereotactic ablative body radiotherapy (SABR), the treatment achieved a 100% local control rate, with 11 patients showing stable disease and 4 experiencing partial responses over a median follow-up of 19 months.

SABR demonstrated minimal toxicity, with only one case of grade 2 acute nausea and two cases of grade 4 renal toxicity in patients with pre-existing severe kidney disease, indicating that it is a safe treatment option for non-surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Primary Renal Cell Carcinoma in Non-surgical Candidates: Initial Clinical Experience. Chang, JH., Cheung, P., Erler, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10698523/

Stereotactic ablative radiotherapy for primary renal cell ... analyzed 81 patients from IROCK with solitary kidneys who underwent SAbR and found a 2-year local control rate of 98 %, with an associated mean ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625061929

Efficacy of Stereotactic Ablative Body Radiotherapy (SABR) ... SABR provides excellent oncologic outcomes, irrespective of ccRCC or nccRCC histology. Introduction. Renal cell carcinoma (RCC) is divided into ...

3. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00656-8/abstract

5-year outcomes after stereotactic ablative body ... SABR is effective and safe in the long term for patients with primary renal cell carcinoma. Single-fraction SABR might yield less local failure ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38423047/

Stereotactic ablative body radiotherapy for primary kidney ... Stereotactic ablative body radiotherapy (SABR) is a novel non-invasive alternative for patients with primary renal cell cancer who do not undergo surgical ...

5. urotoday.com urotoday.com/conference-highlights/astro-2025/astro-2025-kidney-cancer/163517-astro-2025-ultra-hypofractionated-stereotactic-ablative-body-radiotherapy-sabr-for-primary-renal-cell-carcinoma-pooled-outcomes-from-the-fastrack-and-fastrack-ii-clinical-trials.html

ASTRO 2025: Ultra-Hypofractionated Stereotactic Ablative ... 5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data meta-analysis from IROCK (the ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204524000202

Stereotactic ablative body radiotherapy for primary kidney ... S Siva et al. 5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data ...

7. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00138-5/fulltext

Dose-response of localized renal cell carcinoma after ... Safety and efficacy of stereotactic ablative radiation therapy for renal cell cancer: 24-month results of the RSR1 phase 1 dose escalation study.