30 Participants Needed

SBRT for Kidney Cancer

KB
JZ
Overseen ByJialing Zhang, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Yale University
Must be taking: Immune checkpoint inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This Phase II trial will evaluate progression-free survival after Stereotactic Body Radiation Therapy to oligoprogressive (1-5) lesions in metastatic renal cell carcinoma patients on any immune checkpoint inhibitor-containing regimen with last dose of systemic therapy within 3 months prior to trial enrollment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not be on a TKI (a type of cancer medication) as part of your recent treatment, and you should not be on high-dose steroids or other immunosuppressive therapies within two weeks of starting the trial.

What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) for kidney cancer?

Research shows that Stereotactic Ablative Body Radiotherapy (SABR), including the use of CyberKnife, is a promising non-invasive treatment for kidney cancer. It can accurately target tumors while preserving kidney function and has been shown to be feasible and well-tolerated in clinical trials.12345

Is Stereotactic Body Radiation Therapy (SBRT) safe for treating kidney cancer?

Research shows that Stereotactic Body Radiation Therapy (SBRT), also known as Stereotactic Ablative Radiotherapy (SABR) or CyberKnife, is generally well tolerated and safe for treating kidney cancer, with studies indicating it preserves kidney function and is feasible for patients.13678

How is the treatment SBRT for kidney cancer different from other treatments?

SBRT (Stereotactic Body Radiation Therapy) for kidney cancer is unique because it uses precise, high-dose radiation to target tumors while minimizing damage to surrounding healthy kidney tissue, making it a promising option for patients who cannot undergo surgery.12568

Research Team

KJ

Kimberly Johung, MD

Principal Investigator

Yale University

Eligibility Criteria

Adults with metastatic renal cell carcinoma currently on immune checkpoint inhibitors, who have developed 1-5 new lesions. They must not be pregnant or breastfeeding, agree to use effective birth control, and have a life expectancy over 6 months. Excluded are those with recent radiation therapy, live vaccines taken recently, certain autoimmune diseases or infections, brain-only oligoprogression, and serious conditions that preclude radiotherapy.

Inclusion Criteria

I agree to use birth control during and for 6 months after the study.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of SBRT. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Be willing and able to provide written informed consent/assent for the trial
See 7 more

Exclusion Criteria

I've had radiation before, but my current treatment plan meets safe dose limits.
I am currently being treated for an infection.
I received radiation therapy less than 2 weeks ago.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Stereotactic Body Radiation Therapy (SBRT) is delivered to oligoprogressive lesions while continuing immune checkpoint inhibitor regimen

1-5 fractions
Nonconsecutive days for SBRT delivery

Follow-up

Participants are monitored for progression-free survival and overall survival with imaging every three months

Up to two years
Imaging every three months

Long-term monitoring

Long-term monitoring for overall survival and recurrence

Up to two years

Treatment Details

Interventions

  • Stereotactic Body Radiation Therapy
Trial Overview The trial is testing Stereotactic Body Radiation Therapy (SBRT) for patients whose kidney cancer has progressed in a limited number of areas while they're being treated with immune checkpoint inhibitors. The goal is to see if SBRT can stop the cancer from getting worse.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Stereotactic Body Radiation TherapyExperimental Treatment1 Intervention

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Stereotactic Body Radiation Therapy for:
  • Non-small cell lung cancer (NSCLC)
  • Melanoma
  • Renal cell carcinoma (RCC)
  • Prostate cancer
  • Oligoprogressive cancers
🇪🇺
Approved in European Union as Stereotactic Body Radiation Therapy for:
  • Non-small cell lung cancer (NSCLC)
  • Melanoma
  • Renal cell carcinoma (RCC)
  • Prostate cancer
  • Oligoprogressive cancers
🇨🇦
Approved in Canada as Stereotactic Body Radiation Therapy for:
  • Non-small cell lung cancer (NSCLC)
  • Melanoma
  • Renal cell carcinoma (RCC)
  • Prostate cancer
  • Oligoprogressive cancers

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Findings from Research

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.
CyberKnife for inoperable renal tumors: Canadian pioneering experience.Nair, VJ., Szanto, J., Vandervoort, E., et al.[2013]
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.
Reducing the impact on renal function of kidney SABR through management of respiratory motion.Gaudreault, M., Siva, S., Kron, T., et al.[2021]
Stereotactic ablative radiotherapy (SABR) is a safe and well-tolerated treatment for primary renal cell carcinoma (RCC), with a local control rate of 94.4% at both 6 and 12 months in a cohort of 19 patients.
The treatment resulted in minimal acute side effects, with only three patients experiencing Grade 3 toxicity that was manageable, making SABR a promising option for medically unfit patients.
First UK patient cohort treated with stereotactic ablative radiotherapy for primary kidney cancer.Zarkar, A., Henderson, D., Carver, A., et al.[2023]

References

CyberKnife for inoperable renal tumors: Canadian pioneering experience. [2013]
Reducing the impact on renal function of kidney SABR through management of respiratory motion. [2021]
First UK patient cohort treated with stereotactic ablative radiotherapy for primary kidney cancer. [2023]
Stereotactic Ablative Body Radiotherapy for Primary Renal Cell Carcinoma in Non-surgical Candidates: Initial Clinical Experience. [2022]
The emerging roles of stereotactic ablative radiotherapy for metastatic renal cell carcinoma. [2014]
Pooled analysis of stereotactic ablative radiotherapy for primary renal cell carcinoma: A report from the International Radiosurgery Oncology Consortium for Kidney (IROCK). [2022]
The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. [2022]
The Emerging Role of Stereotactic Ablative Radiotherapy for Primary Renal Cell Carcinoma: A Systematic Review and Meta-Analysis. [2022]
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