SBRT for Kidney Cancer

Overseen By Jialing Zhang, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must be taking: Immune checkpoint inhibitors

Must not be taking: TKIs, Immunosuppressants

Disqualifiers: Immunodeficiency, Active infection, 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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1-5 fractions

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This Phase II trial will evaluate progression-free survival after Stereotactic Body Radiation Therapy to oligoprogressive (1-5) lesions in metastatic renal cell carcinoma patients on any immune checkpoint inhibitor-containing regimen with last dose of systemic therapy within 3 months prior to trial enrollment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not be on a TKI (a type of cancer medication) as part of your recent treatment, and you should not be on high-dose steroids or other immunosuppressive therapies within two weeks of starting the trial.

What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) for kidney cancer?

Research shows that Stereotactic Ablative Body Radiotherapy (SABR), including the use of CyberKnife, is a promising non-invasive treatment for kidney cancer. It can accurately target tumors while preserving kidney function and has been shown to be feasible and well-tolerated in clinical trials. ^{1 2 3 4 5}

Is Stereotactic Body Radiation Therapy (SBRT) safe for treating kidney cancer?

Research shows that Stereotactic Body Radiation Therapy (SBRT), also known as Stereotactic Ablative Radiotherapy (SABR) or CyberKnife, is generally well tolerated and safe for treating kidney cancer, with studies indicating it preserves kidney function and is feasible for patients. ^{1 3 6 7 8}

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

SBRT (Stereotactic Body Radiation Therapy) for kidney cancer is unique because it uses precise, high-dose radiation to target tumors while minimizing damage to surrounding healthy kidney tissue, making it a promising option for patients who cannot undergo surgery. ^{1 2 5 6 8}

Research Team

Kimberly Johung, MD

Principal Investigator

Yale University

Eligibility Criteria

Adults with metastatic renal cell carcinoma currently on immune checkpoint inhibitors, who have developed 1-5 new lesions. They must not be pregnant or breastfeeding, agree to use effective birth control, and have a life expectancy over 6 months. Excluded are those with recent radiation therapy, live vaccines taken recently, certain autoimmune diseases or infections, brain-only oligoprogression, and serious conditions that preclude radiotherapy.

Inclusion Criteria

I agree to use birth control during and for 6 months after the study.

Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of SBRT. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Be willing and able to provide written informed consent/assent for the trial

Exclusion Criteria

I've had radiation before, but my current treatment plan meets safe dose limits.

I am currently being treated for an infection.

I received radiation therapy less than 2 weeks ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Stereotactic Body Radiation Therapy (SBRT) is delivered to oligoprogressive lesions while continuing immune checkpoint inhibitor regimen

1-5 fractions

Nonconsecutive days for SBRT delivery

Follow-up

Participants are monitored for progression-free survival and overall survival with imaging every three months

Up to two years

Imaging every three months

Long-term monitoring

Long-term monitoring for overall survival and recurrence

Up to two years

Treatment Details

Interventions

• Stereotactic Body Radiation Therapy

Trial Overview The trial is testing Stereotactic Body Radiation Therapy (SBRT) for patients whose kidney cancer has progressed in a limited number of areas while they're being treated with immune checkpoint inhibitors. The goal is to see if SBRT can stop the cancer from getting worse.

Participant Groups

Group I: Stereotactic Body Radiation Therapy Experimental Treatment 1 Intervention

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Findings from Research

CyberKnife stereotactic ablative body radiotherapy (SABR) was successfully used to treat three patients with kidney tumors, achieving local control in all cases without any reported toxicity.

The treatment preserved kidney function, demonstrating that CyberKnife SABR is a safe and effective option for patients with medically inoperable renal tumors or those with tumors in a solitary kidney.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife for inoperable renal tumors: Canadian pioneering experience. Nair, VJ., Szanto, J., Vandervoort, E., et al.[2013]

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 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]

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 radiotherapy (SABR) shows high local control rates for metastatic renal cell carcinoma (RCC), indicating that these tumors are less radio-resistant than previously believed, making SABR a promising treatment option for symptom palliation and local control.

SABR can potentially eradicate oligometastases, offering a chance for prolonged disease-free survival, and may delay the need for systemic therapy in patients experiencing oligoprogression, while also enhancing the effectiveness of immunotherapy through the immune-modulated abscopal effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging roles of stereotactic ablative radiotherapy for metastatic renal cell carcinoma. Cheung, P., Thibault, I., Bjarnason, GA.[2014]

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 radiotherapy (SABR) for primary renal cell carcinoma (RCC) demonstrated a high local control rate of 97.2% across 26 studies involving 372 patients, indicating its effectiveness even in larger, inoperable tumors.

The treatment was associated with low toxicity, with only 1.5% of patients experiencing grade 3-4 adverse effects, and a minimal change in renal function, suggesting that SABR is a safe option for managing primary RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Stereotactic Ablative Radiotherapy for Primary Renal Cell Carcinoma: A Systematic Review and Meta-Analysis. Correa, RJM., Louie, AV., Zaorsky, NG., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

CyberKnife for inoperable renal tumors: Canadian pioneering experience. [2013]

2. Italy pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

First UK patient cohort treated with stereotactic ablative radiotherapy for primary kidney cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

The emerging roles of stereotactic ablative radiotherapy for metastatic renal cell carcinoma. [2014]

6. 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]

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

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

The Emerging Role of Stereotactic Ablative Radiotherapy for Primary Renal Cell Carcinoma: A Systematic Review and Meta-Analysis. [2022]