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

23 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Stereotactic Ablative Body Radiotherapy (SABR) for kidney cancer?

Research shows that SABR is a promising treatment for kidney cancer, with studies indicating its safety and effectiveness in treating primary renal cell carcinoma, especially in patients who cannot undergo surgery. ^{1 2 3 4 5}

Is SABR safe for treating kidney cancer?

Stereotactic ablative body radiotherapy (SABR) has been studied for kidney cancer, and research shows it is generally safe for patients, including those who cannot have surgery. Studies have focused on its safety and effectiveness, with long-term data supporting its use. ^{2 3 4 5 6}

How is SABR treatment different from other treatments for kidney cancer?

Stereotactic ablative body radiotherapy (SABR) is unique because it is a non-invasive treatment that precisely targets kidney tumors with high doses of radiation, minimizing damage to surrounding healthy tissue. This approach can be particularly beneficial for patients who cannot undergo surgery, and it helps preserve kidney function by reducing the impact of respiratory motion during treatment. ^{2 3 4 5 7}

What is the purpose of this trial?

Hypothesis: Stereotactic ablative body radiation (SAbR) prolongs progression-free survival for patients with oligometastatic kidney cancer (RCC) and delays the initiation of systemic therapy. Primary Objectives: • To evaluate the delay in time to start of systemic therapy (TTST) as a surrogate of progression free survival (PFS), defined as the time from the first day of SAbR to start of systemic therapy. Secondary Objective: * To evaluate the modified progression-free survival (mPFS) for patients with oligometastatic renal cell carcinoma who are treated with SAbR. * To evaluate the overall survival (OS) * To evaluate the cancer specific survival (CSS) * To evaluate the local control rate of irradiated lesions. * To measure the health-related quality of life (HRQOL).

Research Team

Raquibul Hannan, MD, PhD

Principal Investigator

University of Texas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Primary Renal Cell Carcinoma in Non-surgical Candidates: Initial Clinical Experience. [2022]

2. England 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). [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Reducing the impact on renal function of kidney SABR through management of respiratory motion. [2021]

4. United States 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). [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy for inoperable primary kidney cancer: a prospective clinical trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes of High-Dose Stereotactic Ablative Radiotherapy to All/Multiple Sites for Oligometastatic Renal Cell Cancer Patients. [2023]