Stereotactic Ablative Radiation Therapy for Kidney Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.

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

The trial information 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 effectiveness of the treatment Stereotactic Ablative Radiation Therapy for kidney cancer?

Research shows that Stereotactic Ablative Radiation Therapy (SABR) is a promising non-invasive treatment for kidney cancer, with studies indicating it is well tolerated and can maintain kidney function while effectively targeting cancer cells. ^{1 2 3 4 5}

How is Stereotactic Ablative Radiation Therapy different from other treatments for kidney cancer?

Stereotactic Ablative Radiation Therapy (SABR) is unique because it precisely targets kidney tumors with high doses of radiation while minimizing damage to surrounding healthy tissue. This treatment is particularly beneficial for patients with a solitary kidney, as it helps preserve kidney function while effectively shrinking the tumor over time. ^{2 6 7 8 9}

Research Team

Raquibul Hannan, MD, PhD

Principal Investigator

UTSW

Eligibility Criteria

This trial is for adults with small kidney tumors (≤5cm) that have been biopsy-proven and shown growth. Participants must be able to undergo MRI or CT scans, use effective contraception if of childbearing potential, and not be pregnant. Those who've had prior treatments for the renal mass or have metastatic disease (with exceptions) can't join.

Inclusion Criteria

I agree to use effective birth control or abstain from sex during the study.

My kidney tumor was confirmed by a biopsy.

My kidney cancer includes all types, even oncocytoma.

Exclusion Criteria

I have undergone treatments like RFA or cryoablation for my kidney tumor.

I have had radiation therapy to my abdomen before.

I am not pregnant nor planning to become pregnant during the treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy

Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer

1 week

Treatment

Participants undergo treatment with SABR of 3-5 fractions completing within three weeks

3 weeks

Follow-up

Treatment response evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed

2 years

Treatment Details

Interventions

• Stereotactic Ablative Radiation Therapy

Trial Overview The study is testing Stereotactic Ablative Radiation Therapy (SABR), a non-invasive treatment targeting small growing renal tumors. It's a phase II trial aiming to assess how well this therapy works in eliminating cancer cells without surgery.

Participant Groups

Group I: Stereotactic Ablative Radiation Therapy Experimental Treatment 1 Intervention

Stereotactic Ablative Radiation Therapy (SABR)

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

In a study of 74 patients with localized renal cell carcinoma treated with stereotactic body radiotherapy (SBRT), the oncological outcomes were promising, with low rates of local failure (7.77% at 4 years) and distant metastasis (4.24% at 2 years).

However, there was a notable decline in renal function over time, with a median decrease in estimated glomerular filtration rate (eGFR) of -11.5 ml/min at 2 years, particularly in the treated kidney, while the contralateral kidney showed compensatory improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Renal Cell Carcinoma: Oncological and Renal Function Outcomes. Glicksman, RM., Cheung, P., Korol, R., et al.[2023]

Stereotactic body radiotherapy (SBRT) for localized renal cell carcinoma (RCC) was well-tolerated in 19 patients aged 59-89, with no dose-limiting toxicities observed at doses up to 48Gy in 4 fractions.

Among the patients treated, 3 showed a partial response and 12 had stable disease, indicating that SBRT can be an effective treatment option for patients who are poor surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma. Ponsky, L., Lo, SS., Zhang, Y., et al.[2022]

In a study involving 28 patients undergoing stereotactic body radiation therapy (SBRT) for primary kidney cancer, no significant long-term reduction in quality of life (QoL) metrics was observed, indicating that SBRT is a safe treatment option for maintaining QoL post-therapy.

While some patients experienced a temporary decline in global QoL and fatigue at one week post-treatment, most reported stable or improved scores in pain, appetite, and nausea over time, suggesting that SBRT can lead to symptom relief and overall well-being in the months following treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported Quality of Life following Stereotactic Body Radiation Therapy for Primary Kidney Cancer - Results from a Prospective Cohort Study. Swaminath, A., Cheung, P., Glicksman, RM., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First UK patient cohort treated with stereotactic ablative radiotherapy for primary kidney cancer. Zarkar, A., Henderson, D., Carver, A., et al.[2023]

In a clinical trial involving 32 patients with primary kidney cancer, stereotactic ablative body radiation therapy was successfully delivered with minimal intrafraction motion, showing a mean target displacement of only 1.3 mm during treatment.

The study demonstrated that kidney motion was not significantly affected by the presence of tumors, indicating that the treatment can be accurately administered without major adjustments for tumor-related movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guidance and stabilization for stereotactic ablative body radiation therapy (SABR) treatment of primary kidney cancer. Pham, D., Kron, T., Bressel, M., et al.[2018]

Stereotactic body radiation therapy (SBRT) shows over 95% local control for primary renal cell carcinoma (RCC) with limited grade 3-4 toxicity at ≤5%, indicating it is a highly effective and safe treatment option.

For metastatic RCC, SBRT achieves approximately 90% local control at one year, with an even lower incidence of grade 3-4 toxicity at around 1%, suggesting its potential as a preferred treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy options in kidney cancer. Zaorsky, NG., Louie, AV., Siva, S.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Renal Cell Carcinoma: Oncological and Renal Function Outcomes. [2023]

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

Stereotactic Radiotherapy as a Treatment Option for Renal Tumors in the Solitary Kidney: A Multicenter Analysis from the IROCK. [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

Phase I dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Patient-reported Quality of Life following Stereotactic Body Radiation Therapy for Primary Kidney Cancer - Results from a Prospective Cohort Study. [2021]

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

First UK patient cohort treated with stereotactic ablative radiotherapy for primary kidney cancer. [2023]

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

Image guidance and stabilization for stereotactic ablative body radiation therapy (SABR) treatment of primary kidney cancer. [2018]

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

Renal Cancer is Not Radioresistant: Slowly but Continuing Shrinkage of the Tumor After Stereotactic Body Radiation Therapy. [2020]

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

Radiation therapy options in kidney cancer. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Consensus statement from the International Radiosurgery Oncology Consortium for Kidney for primary renal cell carcinoma. [2016]