SBRT for Kidney Cancer

(AQuOS-RCC Trial)

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: ECOG ≥3, Prior abdominal radiation

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: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new kidney cancer treatment called stereotactic body radiotherapy (SBRT). SBRT uses targeted high doses of radiation to attack tumors. The trial aims to assess its effectiveness for kidney cancer patients and its impact on their quality of life. It seeks participants with kidney cancer that has progressed, who are either unable or unwilling to undergo surgery, and have a tumor at least 2.5 cm in size. Participants should understand English or have access to a translator. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for kidney cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this radiotherapy technique is safe for treating kidney cancer?

Research has shown that stereotactic body radiotherapy (SBRT) is generally well-tolerated by patients with kidney cancer. Studies have found that SBRT is a non-invasive treatment that effectively targets tumors with high doses of radiation. Importantly, it has a good safety record, with most patients not experiencing severe side effects.

In past research, many patients reported only mild to moderate side effects, such as fatigue or skin changes in the treated area. Serious complications are rare. This information comes from studies that followed patients for several years, providing a solid understanding of the treatment's safety.

Overall, SBRT is considered a promising and safe option for those who cannot undergo surgery. For those considering joining a trial involving SBRT, these findings suggest that the treatment is generally well-tolerated and has manageable side effects for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for kidney cancer involve surgery, targeted therapy, or immunotherapy. But SBRT, or Stereotactic Body Radiation Therapy, works differently by delivering highly precise, high-dose radiation to the tumor. Unlike traditional radiation, which can affect a larger area and require many sessions, SBRT targets the cancer more accurately and often requires fewer treatments. Researchers are excited because this precision could mean fewer side effects and a more convenient treatment option for patients, potentially improving outcomes and quality of life.

What evidence suggests that SBRT is effective for kidney cancer?

Research has shown that SBRT, a type of radiation therapy, holds promise for treating kidney cancer. This trial will evaluate SBRT's effectiveness in targeting tumors and delivering strong doses of radiation to kill cancer cells. Studies over five years indicate that patients receiving SBRT for kidney cancer experience good cancer control and survival rates. Additionally, SBRT may be a suitable option for patients who cannot undergo surgery. While more research continues, early results are encouraging for using SBRT to treat kidney cancer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who can't have surgery or choose not to, with kidney tumors larger than 2.5cm or recurring after treatment. They should be diagnosed with renal cell carcinoma (RCC) if possible, or show tumor growth on scans.

Inclusion Criteria

My kidney cancer diagnosis was confirmed by a biopsy or by growth seen on scans.

My cancer lesion is larger than 2.5cm or has come back after treatment.

I cannot undergo surgery for medical reasons or I choose not to have surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic body radiation therapy (SBRT) for the treatment of renal cell carcinoma

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for quality of life, oncologic outcomes, and treatment-related toxicity

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• SBRT

Trial Overview The study tests Stereotactic body radiotherapy (SBRT), a high-precision radiation therapy aimed at treating non-surgical patients with RCC to see how it affects their quality of life and cancer control.

How Is the Trial Designed?

Group I: SBRT Experimental Treatment 1 Intervention

RCC patients

SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in European Union as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors
• Bone metastases

Approved in Canada as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Juravinski Cancer Center

Collaborator

Trials

14

Recruited

2,300+

Published Research Related to This Trial

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]

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 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 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 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]

In a study of 21 patients with stage I renal cancer treated with stereotactic body radiation therapy (SBRT), the local tumor control rate was an impressive 100% at 5 years, indicating high efficacy of this noninvasive treatment.

The treatment resulted in only minimal toxicity, with only three patients experiencing grade 1 side effects, suggesting that SBRT is a safe option for patients, especially those who refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nephron-Sparing Robotic Radiosurgical Therapy for Primary Renal Cell Carcinoma: Single-Institution Experience and Review of the Literature. Peddada, AV., Anderson, D., Blasi, OC., et al.[2022]

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]

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 body radiation therapy (SBRT) has been shown to be a safe and effective treatment for localized kidney cancers, achieving over 90% local control with minimal severe toxicity in patients who are not candidates for surgery.

Recent studies indicate that SBRT can effectively treat larger kidney tumors (greater than 5 cm), but further randomized clinical trials are needed to optimize treatment protocols and compare its outcomes to traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Localized Kidney Cancer. Rich, BJ., Noy, MA., Dal Pra, A.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10698523/

Stereotactic ablative radiotherapy for primary renal cell ... 5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data meta-analysis ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2950393024001177

Stereotactic body radiation therapy for primary renal cell ... Over the past decade, numerous retrospective and prospective studies using SABR for the treatment of localized RCC have yielded promising results [4], [5], [6], ...

3. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00020-2/abstract

Stereotactic ablative body radiotherapy for primary kidney ... 5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma ... renal cell carcinoma: results from the Canadian Kidney Cancer ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38423047/

Stereotactic ablative body radiotherapy for primary kidney ... The FASTRACK II clinical trial investigated the efficacy of SABR for primary renal cell cancer in a phase 2 trial. Methods: This international, non-randomised, ...

5. urotoday.com urotoday.com/library-resources/advanced-kidney-cancer/116614-the-current-status-of-stereotactic-body-radiation-therapy-in-kidney-cancer.html

The Current Status of Stereotactic Body Radiation Therapy ... Stereotactic body radiation therapy (SBRT) on renal cell carcinoma, an overview of technical aspects, biological rationale and current literature.

6. practicalradonc.org practicalradonc.org/article/S1879-8500(24)00156-5/abstract

Stereotactic Body Radiation Therapy for Primary Renal ... Real-world practice patterns and safety of concurrent radiotherapy and cabozantinib in metastatic renal cell carcinoma

7. europeanurology.com europeanurology.com/article/S0302-2838(22)02468-X/fulltext

The Role of Stereotactic Ablative Body Radiotherapy in ... Clinical outcomes, safety, and key indications of SABR in RCC are summarised in Fig. 1. Fig. 1 Safety and efficacy of SABR in renal cell ...