70 Participants NeededMy employer runs this trial

Stereotactic Body Radiotherapy for Kidney Cancer

(AQuOS-II Trial)

KD
TT
CZ
Overseen ByChris Zehr
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sunnybrook Health Sciences Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat kidney cancer that cannot be surgically removed, using stereotactic body radiation therapy (SBRT). SBRT targets high doses of radiation on the cancer while sparing surrounding healthy tissue. The trial includes individuals with a primary kidney tumor larger than 3 cm, who cannot or choose not to undergo surgery, and have no cancer spread to other parts of the body. Participants must understand English or have assistance from a translator. As an unphased trial, this study offers a unique opportunity to contribute to innovative research in kidney cancer treatment.

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 for treating kidney cancer. Studies have found that most patients tolerate SBRT well, experiencing only a small decrease in kidney function over two years. This suggests the treatment is manageable for many individuals.

Additionally, data from several studies indicate a low rate of serious side effects. Most patients do not experience severe problems after receiving SBRT. Other studies have used the treatment at doses similar to those planned here, with good safety results.

Overall, the evidence suggests that SBRT is a safe option for individuals with kidney cancer who cannot undergo surgery.12345

Why are researchers excited about this trial?

Stereotactic Body Radiotherapy (SBRT) is unique because it offers a precise, high-dose radiation treatment for kidney cancer, specifically for patients who are medically inoperable. Unlike traditional radiation therapies that often require multiple weeks of treatment, SBRT delivers targeted radiation in just five sessions, minimizing damage to surrounding healthy tissues. Researchers are excited about SBRT because it has the potential to be as effective as surgery, with less risk and recovery time, making it a promising option for patients who cannot undergo surgery.

What evidence suggests that SBRT might be an effective treatment for kidney cancer?

Research has shown that stereotactic body radiotherapy (SBRT) effectively treats renal cell carcinoma (RCC), a type of kidney cancer. A review of studies found that SBRT excels at controlling cancer in the treated area. One study showed that 92% of patients survived for five years due to this treatment. During the same period, about 63.6% of patients experienced no cancer growth or spread. SBRT is also safe in the long term, with some patients experiencing only a small decrease in kidney function. This trial will evaluate SBRT for medically inoperable RCC, offering a promising treatment option for those who cannot undergo surgery.35678

Who Is on the Research Team?

WC

William Chu, MD, FRCPC

Principal Investigator

Sunnybrook Health Sciences Center

Are You a Good Fit for This Trial?

Inclusion Criteria

My main tumor is larger than 3 cm or has come back after local treatment.
I cannot have surgery or have chosen not to have surgery after medical advice.
I have recently been diagnosed with kidney cancer.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic body radiotherapy (SBRT) with 35-45 Gy in five fractions (7-9 Gy/day) for inoperable RCC

1-2 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety, toxicity, and quality of life post-treatment

60 months
Regular visits at months 3, 6, 9, 12, 18, 24, 36, 48, and 60

What Are the Treatments Tested in This Trial?

Interventions

  • SBRT

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SBRT for Medically Inoperable RCCExperimental Treatment1 Intervention

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

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Approved in United States as SBRT for:
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Approved in European Union as SBRT for:
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Approved in Canada as SBRT for:
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Approved in Japan as SBRT for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Health Sciences North

Collaborator

Trials
6
Recruited
1,100+

Juravinski Cancer Center

Collaborator

Trials
14
Recruited
2,300+

St. Joseph's Healthcare Hamilton

Collaborator

Trials
203
Recruited
26,900+

The Ottawa Hospital

Collaborator

Trials
97
Recruited
64,000+

Grand River Regional Cancer Centre

Collaborator

Trials
3
Recruited
60+

British Columbia Cancer Agency

Collaborator

Trials
181
Recruited
95,900+

London Health Sciences Centre

Collaborator

Trials
151
Recruited
60,400+

Durham Regional Cancer Centre

Collaborator

Citations

Stereotactic Body Radiotherapy (SBRT) for the Treatment of ...

The results of the meta-analysis show that SBRT for localised renal cell carcinoma is highly effective in controlling local diseases and has low ...

Articles 5-year outcomes after stereotactic ablative body ...

SABR is effective and safe in the long term for patients with primary renal cell carcinoma. Single-fraction SABR might yield less local failure than ...

5-Year Outcomes With Stereotactic Ablative Body ...

The 5-year estimates were 92.0% (95% CI = 85.2%–95.8%) for cancer-specific survival and 63.6% (95% CI = 55.6%–70.6%) for progression-free ...

Stereotactic Body Radiation Therapy for Renal Tumors

Kidney-directed SBRT results in modest clinical renal function loss up to 2 years following SBRT, based on evaluable patients in our study. Technical advances ...

Is Stereotactic Ablative Radiotherapy for Metastatic Renal ...

SABR has been shown to improve outcomes including overall survival (OS) for patients with oligometastatic cancers.

5-year outcomes after stereotactic ablative body ...

The primary aim of this study was to report on long-term efficacy and safety of SABR for localised renal cell carcinoma. Methods. This study was ...

Safety and Efficacy of Stereotactic Ablative Radiation Therapy ...

Conclusions. SAbR demonstrated excellent LC of metastatic renal cell carcinoma with a favorable safety profile when an adequate dose and coverage were applied.

Safety and Efficacy of Stereotactic Ablative Radiation ...

The findings suggest that our last dose level of 48 Gy in 4 12-Gy fractions can be considered safe, and it will be used for our subsequent phase 2 study.