Stereotactic Ablative Radiation Therapy for Kidney Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Previous abdominal radiation, Metastatic disease, Pregnancy, 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: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, completely non-invasive treatment called stereotactic radiation therapy for small kidney tumors. The goal is to evaluate the effectiveness of this radiation therapy in treating biopsy-confirmed kidney cancer that is increasing in size. It suits adults with a kidney tumor that is 5 cm or smaller and has grown over 2 mm in the past year. Participants must be able to undergo an MRI or a CT scan with a contrast agent. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that stereotactic ablative radiation therapy is safe for treating kidney cancer?

Research has shown that Stereotactic Ablative Radiation Therapy (SABR) is usually well-tolerated for treating kidney cancer. In a previous study, SABR demonstrated a strong safety record, with no serious side effects or treatment-related deaths reported over five years. This indicates that most people did not experience severe problems from the treatment.

Other studies support these findings, showing that SABR is effective and safe for kidney cancer patients in the long term. Even at higher doses for smaller tumors, SABR succeeded without causing significant harm to patients.

The current trial is in its second phase, so researchers are still closely monitoring the treatment's safety. However, early evidence suggests it is promising. This is encouraging for those considering joining a trial, knowing that the treatment is likely safe based on past studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic Ablative Radiation Therapy (SABR) is unique because it offers a highly precise way to target kidney cancer, unlike traditional treatments like surgery or conventional radiation. It uses advanced imaging to deliver high doses of radiation directly to the tumor with minimal impact on surrounding healthy tissue. This precision reduces side effects and can potentially improve recovery times. Researchers are excited because SABR could offer an effective and non-invasive alternative to surgery, making treatment easier for patients and potentially improving outcomes.

What evidence suggests that stereotactic ablative radiation therapy is effective for kidney cancer?

Research has shown that Stereotactic Ablative Radiation Therapy (SABR), the treatment under study in this trial, effectively treats small kidney tumors. One study found that SABR successfully controlled tumors in 98% of cases over two years, meaning the tumors did not grow in almost all patients. Other studies have reported control rates between 70% and 100%. SABR is also considered safe in the long term, with few serious side effects. Overall, SABR presents a promising non-invasive treatment option for kidney cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Raquibul Hannan, MD, PhD

Principal Investigator

UTSW

Are You a Good Fit for This Trial?

This trial is for adults with small kidney tumors (≤5cm) that have been biopsy-proven and shown growth. Participants must be able to undergo MRI or CT scans, use effective contraception if of childbearing potential, and not be pregnant. Those who've had prior treatments for the renal mass or have metastatic disease (with exceptions) can't join.

Inclusion Criteria

I agree to use effective birth control or abstain from sex during the study.

My kidney tumor was confirmed by a biopsy.

My kidney cancer includes all types, even oncocytoma.

Exclusion Criteria

I have undergone treatments like RFA or cryoablation for my kidney tumor.

I have had radiation therapy to my abdomen before.

I am not pregnant nor planning to become pregnant during the treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy

Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer

1 week

Treatment

Participants undergo treatment with SABR of 3-5 fractions completing within three weeks

3 weeks

Follow-up

Treatment response evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Ablative Radiation Therapy

Trial Overview The study is testing Stereotactic Ablative Radiation Therapy (SABR), a non-invasive treatment targeting small growing renal tumors. It's a phase II trial aiming to assess how well this therapy works in eliminating cancer cells without surgery.

How Is the Trial Designed?

Group I: Stereotactic Ablative Radiation Therapy Experimental Treatment 1 Intervention

Stereotactic Ablative Radiation Therapy (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

In a clinical trial involving 32 patients with primary kidney cancer, stereotactic ablative body radiation therapy was successfully delivered with minimal intrafraction motion, showing a mean target displacement of only 1.3 mm during treatment.

The study demonstrated that kidney motion was not significantly affected by the presence of tumors, indicating that the treatment can be accurately administered without major adjustments for tumor-related movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guidance and stabilization for stereotactic ablative body radiation therapy (SABR) treatment of primary kidney cancer. Pham, D., Kron, T., Bressel, M., et al.[2018]

In a study involving 28 patients undergoing stereotactic body radiation therapy (SBRT) for primary kidney cancer, no significant long-term reduction in quality of life (QoL) metrics was observed, indicating that SBRT is a safe treatment option for maintaining QoL post-therapy.

While some patients experienced a temporary decline in global QoL and fatigue at one week post-treatment, most reported stable or improved scores in pain, appetite, and nausea over time, suggesting that SBRT can lead to symptom relief and overall well-being in the months following treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported Quality of Life following Stereotactic Body Radiation Therapy for Primary Kidney Cancer - Results from a Prospective Cohort Study. Swaminath, A., Cheung, P., Glicksman, RM., et al.[2021]

In a study of 74 patients with localized renal cell carcinoma treated with stereotactic body radiotherapy (SBRT), the oncological outcomes were promising, with low rates of local failure (7.77% at 4 years) and distant metastasis (4.24% at 2 years).

However, there was a notable decline in renal function over time, with a median decrease in estimated glomerular filtration rate (eGFR) of -11.5 ml/min at 2 years, particularly in the treated kidney, while the contralateral kidney showed compensatory improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Renal Cell Carcinoma: Oncological and Renal Function Outcomes. Glicksman, RM., Cheung, P., Korol, R., et al.[2023]

Stereotactic body radiotherapy (SBRT) for localized renal cell carcinoma (RCC) was well-tolerated in 19 patients aged 59-89, with no dose-limiting toxicities observed at doses up to 48Gy in 4 fractions.

Among the patients treated, 3 showed a partial response and 12 had stable disease, indicating that SBRT can be an effective treatment option for patients who are poor surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma. Ponsky, L., Lo, SS., Zhang, Y., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is a safe and well-tolerated treatment for primary renal cell carcinoma (RCC), with a local control rate of 94.4% at both 6 and 12 months in a cohort of 19 patients.

The treatment resulted in minimal acute side effects, with only three patients experiencing Grade 3 toxicity that was manageable, making SABR a promising option for medically unfit patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First UK patient cohort treated with stereotactic ablative radiotherapy for primary kidney cancer. Zarkar, A., Henderson, D., Carver, A., et al.[2023]

Stereotactic body radiation therapy (SBRT) shows over 95% local control for primary renal cell carcinoma (RCC) with limited grade 3-4 toxicity at ≤5%, indicating it is a highly effective and safe treatment option.

For metastatic RCC, SBRT achieves approximately 90% local control at one year, with an even lower incidence of grade 3-4 toxicity at around 1%, suggesting its potential as a preferred treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy options in kidney cancer. Zaorsky, NG., Louie, AV., Siva, S.[2023]

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/S2950393024001177

Stereotactic body radiation therapy for primary renal cell ... Studies report local control rates ranging from 70% to 100% with SABR, highlighting its efficacy in treating RCC. The decline in glomerular filtration rate (GFR) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36400098/

an individual patient data meta-analysis from IROCK (the ... SABR is effective and safe in the long term for patients with primary renal cell carcinoma. Single-fraction SABR might yield less local failure than ...

4. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00122-8/fulltext

Stereotactic Radiation Therapy for the Treatment of ... One-year overall survival was 82.2%, progression-free survival was 48.2%, and local control was 95.9%. Acute grade 2 and 3 toxicity related to SABR was 7.4%.

5. 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 ...

6. actionkidneycancer.org actionkidneycancer.org/5-year-outcomes-after-sabr-for-primary-kidney-cancer/

5-year outcomes after SABR for primary kidney cancer SABR failure rate at 5 years was 5·5% overall. There were no serious side effects or treatment-related deaths. SABR is effective and safe in the long term.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28587057/

Safety and Efficacy of Stereotactic Ablative Radiation Therapy ... SAbR demonstrated excellent LC of metastatic renal cell carcinoma with a favorable safety profile when an adequate dose and coverage were applied.

8. sciencedirect.com sciencedirect.com/science/article/pii/S240563082400168X

Stereotactic ablative radiotherapy for primary kidney cancer Expected outcomes were generally high in terms of local control, favoring higher rates for small vs large renal masses. Abstract. Purpose. To conduct an ...

9. 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.