SABR for Kidney Cancer

Overseen By Lilianna Robles

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Brain metastases, Pulmonary embolism, Pulmonary hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2-3 weeks

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants may have received other investigational agents or chemotherapy as long as they are eligible for SABR and surgery.

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

Research shows that SABR is a promising non-invasive treatment for kidney cancer, achieving high local control rates and being well tolerated by patients. Studies have demonstrated its effectiveness in both primary and metastatic renal cell carcinoma, with favorable outcomes and potential benefits when combined with other therapies. ^{1 2 3 4 5}

Is SABR safe for treating kidney cancer?

Stereotactic Ablative Radiotherapy (SABR) for kidney cancer has been shown to have a favorable safety profile, with studies indicating it is generally safe for humans, even in patients with impaired kidney function. ^{2 3 5 6 7}

How is the treatment SABR unique for kidney cancer?

Stereotactic Ablative Radiation Therapy (SABR) is unique for kidney cancer because it precisely targets the tumor with high doses of radiation while minimizing damage to surrounding healthy kidney tissue, especially by managing respiratory motion. This makes it a promising option for patients who may not be suitable for surgery. ^{1 2 3 8 9}

What is the purpose of this trial?

To evaluate the safety and feasibility of pre-operative SABR of RCC IVC tumor thrombus. To evaluate the effect of pre-operative SABR in RCC IVC tumor thrombus on relapse free survival at one year.

Research Team

Raquibul Hannan, MD

Principal Investigator

UTSW

Eligibility Criteria

This trial is for adults with kidney cancer that has spread to the large vein (IVC) carrying blood from the lower body to the heart. Participants must be able to have an MRI or CT scan, be in fair health (ECOG 0-2), and use birth control if needed. They should agree to surgery after radiation therapy and can join even with treated metastases elsewhere.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent

My albumin level is at least 3.4 g/dL or higher.

I agree to use birth control during the study.

Exclusion Criteria

I have had radiation therapy close to my IVC tumor.

Contraindication for contrast-enhanced MRI as defined by the standard operating procedures of the Department of Radiology at UT Southwestern

I can have surgery and SABR even if I've had other experimental treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant SABR for IVC tumor thrombus, followed by IVC tumor thrombectomy

2-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pulmonary metastasis and systemic metastasis

1 year

Long-term follow-up

Participants are monitored for long-term outcomes such as overall survival and recurrence

7 years

Treatment Details

Interventions

• Stereotactic Ablative Radiation Therapy

Trial Overview The study tests pre-operative Stereotactic Ablative Radiation Therapy (SABR) on IVC tumor thrombus in kidney cancer patients. It aims to assess safety, feasibility, and whether this treatment before surgery can help patients remain free of cancer one year post-treatment.

Participant Groups

Group I: Stereotactic ablative radiation therapy Experimental Treatment 1 Intervention

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

Stereotactic ablative radiotherapy (SABR) shows high local control rates for metastatic renal cell carcinoma (RCC), indicating that these tumors are less radio-resistant than previously believed, making SABR a promising treatment option for symptom palliation and local control.

SABR can potentially eradicate oligometastases, offering a chance for prolonged disease-free survival, and may delay the need for systemic therapy in patients experiencing oligoprogression, while also enhancing the effectiveness of immunotherapy through the immune-modulated abscopal effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging roles of stereotactic ablative radiotherapy for metastatic renal cell carcinoma. Cheung, P., Thibault, I., Bjarnason, GA.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 well-tolerated and effective treatment for primary renal cell carcinoma, showing high rates of local control (97.8%) and cancer-specific survival (95.7%) at 2 years among 223 patients studied across multiple institutions.

Patients receiving single-fraction SABR had better progression-free survival and cancer-specific survival compared to those receiving multifraction SABR, suggesting that single-fraction treatment may be more beneficial for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled analysis of stereotactic ablative radiotherapy for primary renal cell carcinoma: A report from the International Radiosurgery Oncology Consortium for Kidney (IROCK). Siva, S., Louie, AV., Warner, A., et al.[2022]

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]

Stereotactic ablative radiotherapy (SAbR) is a promising non-invasive treatment for primary renal cell carcinoma (RCC), showing high local control rates and a favorable safety profile across multiple studies.

Emerging evidence suggests that SAbR may have immunomodulatory effects, leading to ongoing clinical investigations of its use in combination with other treatments for metastatic RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for primary renal cell carcinoma. Yang, DX., Kwon, YS., Timmerman, R., et al.[2023]

Stereotactic ablative body radiotherapy (SABR) has shown a local control rate of over 90% in treating primary renal cell carcinoma (RCC) across 589 cases, with low rates of severe toxicity (grade 3-4) ranging from 0-9%.

In patients with oligometastatic RCC, SABR can delay the need for systemic therapy for at least one year in 70-90% of cases, indicating its effectiveness as a treatment option and its compatibility with systemic therapies like targeted therapy or immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. Ali, M., Mooi, J., Lawrentschuk, N., et al.[2022]

Stereotactic ablative radiotherapy (SABR) for primary renal cell carcinoma (RCC) demonstrated a high local control rate of 97.2% across 26 studies involving 372 patients, indicating its effectiveness even in larger, inoperable tumors.

The treatment was associated with low toxicity, with only 1.5% of patients experiencing grade 3-4 adverse effects, and a minimal change in renal function, suggesting that SABR is a safe option for managing primary RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Stereotactic Ablative Radiotherapy for Primary Renal Cell Carcinoma: A Systematic Review and Meta-Analysis. Correa, RJM., Louie, AV., Zaorsky, NG., et al.[2022]

References

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

The emerging roles of stereotactic ablative radiotherapy for metastatic renal cell carcinoma. [2014]

2. Italy pubmed.ncbi.nlm.nih.gov

Reducing the impact on renal function of kidney SABR through management of respiratory motion. [2021]

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

Pooled analysis of stereotactic ablative radiotherapy for primary renal cell carcinoma: A report from the International Radiosurgery Oncology Consortium for Kidney (IROCK). [2022]

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

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

5. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for primary renal cell carcinoma. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Robotic stereotactic ablative radiotherapy for renal cell carcinoma in patients with impaired renal function. [2020]

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

Safety and Efficacy of Stereotactic Ablative Radiation Therapy for Renal Cell Carcinoma Extracranial Metastases. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The Emerging Role of Stereotactic Ablative Radiotherapy for Primary Renal Cell Carcinoma: A Systematic Review and Meta-Analysis. [2022]