SABR for Kidney Cancer

Recruiting at 1 trial location

Overseen By Andrew McPartlin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Endocrine therapy

Disqualifiers: Active metastases, Prior radiotherapy, End stage renal failure, Familial syndrome, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 week

45 Participants Needed

Trial Summary

What is the purpose of this trial?

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that systemic therapy (except hormone therapy) should not be taken within 6 days before starting the trial treatment.

What data supports the effectiveness of the treatment SABR for kidney cancer?

Research shows that SABR is a promising non-invasive treatment for kidney cancer, achieving high local control rates and having a favorable safety profile. Studies have demonstrated its effectiveness in treating primary renal cell carcinoma, especially when surgery is not suitable. ^{1 2 3 4 5}

Is SABR safe for treating kidney cancer?

SABR (Stereotactic Ablative Body Radiotherapy) has been studied for kidney cancer, and research shows it is generally safe for humans, with studies focusing on its safety and effects on kidney function. ^{1 2 3 6 7}

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

SABR (Stereotactic Ablative Body Radiotherapy) 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 and potentially preserving kidney function. ^{1 2 3 8 9}

Research Team

Andrew McPartlin, MD

Principal Investigator

The Princess Margaret Cancer Foundation

Eligibility Criteria

This trial is for patients with a solid kidney mass suitable for SABR treatment, specifically those who have primary RCC or metastasis up to 6cm. It's aimed at people who are high-risk for surgery or have declined it, and can still perform daily activities (ECOG status 0-3). Those with multiple active metastases, recent systemic therapy, prior overlapping abdominal radiotherapy, end-stage renal failure, or certain genetic syndromes cannot participate.

Inclusion Criteria

My kidney tumor was confirmed by a biopsy or scan.

I am able to care for myself but may not be able to do heavy physical work.

I have a kidney tumor smaller than 6cm suitable for targeted radiation.

Exclusion Criteria

I have a genetic condition like Von Hippel-Lindau disease or Polycystic Kidney Disease.

I've had radiotherapy on my abdomen that affected my kidney with high doses.

My kidney function is severely reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Ablative Radiosurgery (SABR) for renal tumors

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and standard of care imaging

2 years

Follow-ups every 4 months

Treatment Details

Interventions

• SABR

Trial Overview The study is testing Stereotactic Ablative Radiotherapy (SABR) as a non-surgical option for treating renal tumors. Patients will receive high-dose radiation targeting the tumor while sparing surrounding organs. They'll be monitored before and after treatment and every four months over two years to assess their quality of life and changes in the tumor through standard imaging.

Participant Groups

Group I: Stereotactic Ablative Radiotherapy Experimental Treatment 1 Intervention

Adult patients with Kidney mass (either primary or metastasis) amenable to SABR

SABR is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as SABR for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United States as SABR for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United Kingdom as SABR for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

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) 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 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 radiotherapy (SAbR) is a promising non-invasive treatment for primary renal cell carcinoma (RCC), showing high local control rates and a favorable safety profile across multiple studies.

Emerging evidence suggests that SAbR may have immunomodulatory effects, leading to ongoing clinical investigations of its use in combination with other treatments for metastatic RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for primary renal cell carcinoma. Yang, DX., Kwon, YS., Timmerman, R., et al.[2023]

The RAPPORT trial demonstrated that stereotactic ablative body radiotherapy (SABR) combined with pembrolizumab is well tolerated in patients with oligometastatic clear cell renal cell carcinoma (ccRCC), with only 13% experiencing grade 3 treatment-related adverse events and no severe (grade 4 or 5) adverse events reported.

The treatment showed promising efficacy, with an overall response rate of 63%, a disease control rate of 83%, and a 2-year overall survival rate of 74%, indicating that this regimen could provide durable responses and effective local control in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Radiotherapy and Short-course Pembrolizumab for Oligometastatic Renal Cell Carcinoma-The RAPPORT Trial. Siva, S., Bressel, M., Wood, ST., 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]

In a study assessing the effects of stereotactic ablative body radiotherapy (SABR) on a patient with a solitary kidney, renal function declined significantly, showing a 34% decrease at 3 months and stabilizing at a 43% loss by 12 months after receiving a single dose of 26 Gy.

The research indicates a clear dose-effect relationship, where the extent of kidney function loss correlates with the radiation dose delivered, highlighting the need for careful consideration of SABR's impact on healthy renal tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short communication: timeline of radiation-induced kidney function loss after stereotactic ablative body radiotherapy of renal cell carcinoma as evaluated by serial (99m)Tc-DMSA SPECT/CT. Jackson, P., Foroudi, F., Pham, D., 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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

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

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. 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]

4. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for primary renal cell carcinoma. [2023]

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

Stereotactic Radiotherapy and Short-course Pembrolizumab for Oligometastatic Renal Cell Carcinoma-The RAPPORT Trial. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Short communication: timeline of radiation-induced kidney function loss after stereotactic ablative body radiotherapy of renal cell carcinoma as evaluated by serial (99m)Tc-DMSA SPECT/CT. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

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