CyberKnife for Kidney Cancer

Overseen By Kaitlyn Scott-Haughey, M.Ed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Coagulopathies, Prior abdominal irradiation, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of CyberKnife, a precise radiation treatment, for kidney cancer. The goal is to determine if this technology can effectively target and treat Stage I renal cell carcinoma, a type of kidney cancer that hasn't spread. The trial delivers radiation over a few days to limit exposure to surrounding healthy tissue. Individuals diagnosed with Stage I renal cell carcinoma and without other cancers in the past two years might be suitable candidates for this study. As an unphased trial, this study provides an opportunity to explore innovative treatment options for kidney cancer.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that CyberKnife Radiosurgery is safe for treating kidney cancer?

Research has shown that CyberKnife, a precise radiation therapy, is generally well-tolerated by patients with kidney cancer. Studies have found that it can safely target tumors with high doses of radiation while protecting nearby healthy organs. For example, doses up to 60 Gy over three sessions were safely used in patients with localized kidney cancer. Patients in those studies maintained good kidney function after treatment, with few reports of serious side effects. This suggests that CyberKnife is a promising and safe option for treating kidney cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CyberKnife treatment is unique because it uses advanced robotic radiosurgery to deliver precise doses of radiation directly to kidney tumors. Unlike traditional surgery or standard radiation therapy, which may involve longer recovery times or impact surrounding healthy tissues, CyberKnife offers a non-invasive option that targets only the tumor. This method is particularly exciting because it can be completed in just 3–4 days, potentially leading to quicker recovery and fewer side effects for patients. Researchers are optimistic about its ability to provide effective treatment while minimizing harm to the rest of the kidney and nearby organs.

What evidence suggests that CyberKnife is effective for kidney cancer?

Research has shown that CyberKnife radiosurgery, the treatment under study in this trial, effectively treats kidney cancer that hasn't spread. A review of several studies found that Stereotactic Body Radiotherapy (SBRT), similar to CyberKnife, excels at stopping tumor growth or spread. Another large study found that treatments like CyberKnife successfully controlled the cancer and maintained kidney function for five years. These studies suggest that CyberKnife could be a strong option for people with localized kidney cancer, offering precise treatment while protecting nearby healthy tissue. ^{1 2 3 4 6}

Who Is on the Research Team?

Irving D Kaplan, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with Stage I renal cell carcinoma (kidney cancer) no larger than 8 cm, who can have a gold marker placed near the tumor and are expected to live at least another year. They must not have had other cancers in the last 2 years (except non-invasive skin cancers), be able to undergo CT/MRI scans, and use contraception.

Inclusion Criteria

At least one (usually up to 3) gold fiducial placed in or around tumor, can be performed on the same day - after signing research informed consent

You have a good level of physical ability, with minimal limitations in daily activities.

You are expected to live for at least 12 more months.

Exclusion Criteria

You have a condition that prevents the placement of fiducials due to blood clotting issues.

You have received radiation therapy in your upper abdomen before.

You have had another type of cancer in the past 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multiple visits for tests and procedures

Treatment

Participants receive Cyberknife Radiosurgery treatments over 3-14 days

1-2 weeks

Daily visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Annual phone calls

What Are the Treatments Tested in This Trial?

Interventions

• CyberKnife

Trial Overview The study tests CyberKnife Radiosurgery's effectiveness on localized kidney cancer. This technology delivers high radiation doses directly to tumors while sparing nearby organs, potentially increasing treatment success.

How Is the Trial Designed?

Group I: Cyberknife Experimental Treatment 1 Intervention

You will receive a series of Cyberknife Radiosurgery treatments, with the amount of radiation dosing adjusted for the size of your tumor. The treatment will ideally take place over the course of 3-4 days, but not more than 14 days overall. (3 or 4 fractions of radiation therapy delivered by cyberknife)

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

Approved in United States as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Approved in European Union as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Approved in Canada as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

In a study of 33 patients with low- and intermediate-risk prostate cancer treated with CyberKnife SBRT, there was no biochemical failure, indicating high efficacy of the treatment over a median follow-up of 51 months.

The treatment resulted in manageable side effects, with no grade 3 acute or late toxicities reported, and most acute complications resolved within 2 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. Kim, HJ., Phak, JH., Kim, WC.[2022]

CyberKnifeTM stereotactic body radiotherapy (SBRT) showed effectiveness in reducing the size of tumors in patients with advanced pancreaticobiliary malignancies, with an average decrease in tumor size observed in the first three months after treatment.

However, serious complications were reported, including two cases of massive duodenal ulcer bleeding, highlighting the need for careful monitoring and further studies to evaluate the safety and long-term efficacy of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An experience of cyberknife treatment in patients with advanced pancreaticobilliary malignancy]. Jung, YH., Choi, HS., Cheon, YK., et al.[2019]

Stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer was found to be safe, with no severe treatment-related toxicities (grade 3 or higher) reported among 44 patients over a median follow-up of 40 months.

The treatment showed excellent efficacy, with a 100% cause-specific survival rate and progression-free survival rate, and a high biochemical failure-free rate of 90.8% for high-risk patients, particularly with the 34 Gy in 4 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic body radiation therapy for localized prostate cancer. Kang, JK., Cho, CK., Choi, CW., et al.[2022]

Cyberknife stereotactic body radiation therapy (SBRT) demonstrated a 2-year overall survival rate of 64.0% in patients with recurrent hepatocellular carcinoma (HCC), significantly better than the 42.1% survival rate in matched controls not receiving SBRT.

The treatment was found to be safe, with only mild and tolerable acute toxicities, indicating that SBRT is an effective option for improving survival in patients with unresectable HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy in recurrent hepatocellular carcinoma. Huang, WY., Jen, YM., Lee, MS., et al.[2022]

Cyberknife stereotactic body radiation therapy (SBRT) delivers high doses of radiation in fewer sessions, making it a promising alternative to surgery for early-stage primary cancers and for patients with oligometastatic disease.

Despite some uncertainties about the effects of hypofractionation, early results show good local control and patient tolerance, leading to increased use of this treatment under strict quality assurance and ongoing clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. Thariat, J., Marcié, S., Marcy, PY., et al.[2018]

In a study of 29 prostate cancer patients treated with stereotactic body radiotherapy (SBRT) using a Cyberknife, PSA levels showed a significant decrease over time, with a median nadir of 0.329 ng/mL achieved after 23 months.

The treatment demonstrated a favorable safety profile, with only 3% of patients experiencing Grade 2 urinary toxicities and no severe late rectal toxicities reported, indicating that SBRT is a feasible option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. Lee, YH., Son, SH., Yoon, SC., et al.[2022]

Cyberknife stereotactic body radiation therapy (SBRT) was found to be safe and effective for treating unresectable huge hepatocellular carcinoma (HCC), with an objective response rate of 86.3% and a median survival of 11 months among 22 patients treated between 2009 and 2011.

The study indicated that the dose of SBRT significantly influenced survival outcomes, with a 1-year overall survival rate of 50%, suggesting that SBRT could be a viable salvage treatment option for patients with large HCC, despite the risk of local and regional recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of stereotactic body radiation therapy on huge hepatocellular carcinoma unsuitable for other local modalities. Que, JY., Lin, LC., Lin, KL., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11475739/

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

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01890590

A Phase II Study of Cyberknife Radiosurgery for Renal Cell ... The purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of clinically localized primary renal cell carcinoma.

3. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00513-2/abstract

Stereotactic body radiotherapy for primary renal cell ... This systematic review was performed to assess the safety and efficacy of SBRT for primary renal cell carcinoma. Review results then formed the basis for the ...

4. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/renal-cancer/158784-results-of-stereotactic-body-radiation-therapy-for-primary-renal-cell-carcinoma-in-a-large-multicenter-series-beyond-the-abstract.html

Results of Stereotactic Body Radiation Therapy for Primary ... 5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data meta-analysis ...

5. cyberknifemiami.com cyberknifemiami.com/non-surgical-kidney-cancer-treatment-with-cyberknife-radiation-therapy/

Non-Surgical Kidney Cancer Treatment With ... This large series of primary RCC treated with SBRT (like CyberKnife) demonstrates excellent LC and renal function preservation, and is associated with an ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2468294223000138

Stereotactic body radiation therapy to the kidney for ... The safety of SBRT to the kidney with doses up to 60 Gy in 3 fractions has been established in dose escalation studies treating localized renal cell carcinoma.