CyberKnife for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Irving D Kaplan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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.

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. ^{1 5 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 3 4 5 6}

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

Age ≥ 18 years old

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.

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.

Treatment Details

Interventions

• CyberKnife (Radiation Therapy)

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 Canada for the following indications:

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+

Dr. Kevin Tabb

Beth Israel Deaconess Medical Center

Chief Executive Officer since 2021

MD from Hebrew University Hadassah Medical School

Dr. Chi Chang Daniel Siao

Beth Israel Deaconess Medical Center

Chief Medical Officer since 2023

MD from King George’s Medical University

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

Findings from Research

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

4. Canada pubmed.ncbi.nlm.nih.gov

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

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

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