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

Trial Summary

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 data supports the idea that CyberKnife for Kidney Cancer is an effective treatment?

The available research shows that CyberKnife can effectively treat kidney tumors by delivering precise radiation doses while preserving kidney function. This is based on Canada's pioneering experience with CyberKnife for primary kidney tumors, indicating its potential as a promising treatment option. ^{1 2 3 4 5}

What safety data exists for CyberKnife treatment?

The safety of CyberKnife, also known as stereotactic body radiation therapy (SBRT), has been evaluated in various studies for different types of cancer. Studies have shown promising results in terms of local control and tolerance, particularly for prostate cancer and hepatocellular carcinoma. The treatment is considered safe and feasible, with indications increasing under strict quality assurance programs. However, there are still some uncertainties regarding the radiobiology of hypofractionation. ^{3 4 6 7 8}

Is CyberKnife a promising treatment for kidney cancer?

Yes, CyberKnife is a promising treatment for kidney cancer. It can accurately target and treat kidney tumors while preserving kidney function. It is considered a novel approach that can be an alternative to surgery, especially for early-stage cancer, and aims to improve quality of life. ^{1 2 3 4 6}

What is the purpose of this trial?

CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the efficacy of radiation treatment. Currently, radiosurgery is commonly used for brain metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of clinically localized primary renal cell carcinoma.

Research Team

Irving D Kaplan, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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) 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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

[An experience of cyberknife treatment in patients with advanced pancreaticobilliary malignancy]. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

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

3. Australia pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]

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

Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. [2018]

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

Stereotactic body radiation therapy in recurrent hepatocellular carcinoma. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The efficacy of stereotactic body radiation therapy on huge hepatocellular carcinoma unsuitable for other local modalities. [2022]