SBRT for Kidney Cancer

Overseen By Patricia Brand

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Stereotactic Body Radiation Therapy (SBRT) for individuals with kidney cancer that has spread. The main goal is to determine if SBRT can prevent cancer progression when combined with immune therapy drugs. This trial suits those with kidney cancer and up to five areas of new or growing cancer despite ongoing immune therapy treatments. Participants should have received their last dose of immune therapy within the past three months and have a life expectancy of more than six months. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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 prior data suggests that Stereotactic Body Radiation Therapy is safe for treating kidney cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) is generally safe and well-tolerated for treating kidney cancer. Studies have found that SBRT can deliver high doses of radiation in just a few sessions, effectively controlling tumor growth with few side effects. One study confirmed that SBRT was well-tolerated for treating primary kidney cancer, even at higher doses. Another study found that SBRT was effective and safe for long-term treatment, with minimal chances of the cancer returning at the treatment site and low rates of complications. Overall, these findings suggest that SBRT is a promising option with manageable risks for kidney cancer patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic Body Radiation Therapy (SBRT) for kidney cancer is unique because it delivers high doses of radiation precisely to the tumor in a few treatment sessions, minimizing damage to surrounding healthy tissue. Unlike traditional radiation therapy, which often involves multiple smaller doses over several weeks, SBRT is designed for faster and more targeted treatment. Researchers are excited about SBRT because it offers the potential for improved precision and effectiveness, reducing the treatment burden on patients and potentially leading to better outcomes compared to conventional options like surgery or prolonged radiation courses.

What evidence suggests that Stereotactic Body Radiation Therapy is effective for kidney cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) effectively treats renal cell carcinoma, a type of kidney cancer. One study found that among 81 patients with only one kidney, SBRT had a 98% success rate in controlling cancer in the treated area for two years. Other studies report success rates between 70% and 100%, indicating SBRT's effectiveness in targeting and managing the disease. In another group with larger tumors, SBRT proved successful, with no cancer recurrence or cancer-related deaths. The treatment also has a low rate of serious side effects, making it a promising option for kidney cancer patients. Participants in this trial will receive SBRT to further evaluate its effectiveness and safety. ^{1 5 6 7 8}

Who Is on the Research Team?

Kimberly Johung, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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 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) 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) 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]

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]

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