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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating kidney cancer that has spread to a major blood vessel near the heart. Researchers aim to determine if using a specialized type of radiation therapy, known as Stereotactic Ablative Radiation Therapy (SABR), before surgery can improve patient outcomes by assessing safety and its ability to prevent cancer recurrence after one year. Individuals with kidney cancer that has extended into the vena cava (a large vein) and who qualify for both radiation therapy and surgery may be suitable candidates. As a Phase 1, Phase 2 trial, this study focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that Stereotactic Ablative Radiation Therapy is likely to be safe for humans?

Research has shown that Stereotactic Ablative Radiation Therapy (SABR) is generally safe for treating kidney cancer. Studies have found that SABR maintains a good safety record for kidney cancer that has spread, causing few serious side effects. One study found that over five years, SABR rarely failed, and no treatment-related deaths occurred. This suggests patients tolerated the treatment well. Overall, SABR has proven to be an effective and safe long-term option for treating kidney cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic Ablative Radiation Therapy (SABR) is unique because it delivers high doses of radiation precisely to kidney tumors, minimizing damage to surrounding healthy tissue. Unlike traditional radiation therapy, which often requires multiple sessions over several weeks, SABR can be completed in just a few treatments, making it more convenient for patients. Researchers are excited about SABR because it has the potential to effectively target cancer cells with fewer side effects and a quicker recovery time compared to standard options like surgery or conventional radiation therapy.

What evidence suggests that Stereotactic Ablative Radiation Therapy might be an effective treatment for kidney cancer?

Research has shown that Stereotactic Ablative Radiation Therapy (SABR), which participants in this trial will receive, holds promise for treating kidney cancer, known as renal cell carcinoma (RCC). Studies indicate that SABR can effectively control cancer growth in most patients, with success rates ranging from 70% to 100%. One study found that SABR achieved a 98% success rate in controlling the cancer over two years, demonstrating its effectiveness in preventing recurrence or spread. Long-term evidence also supports SABR's safety and effectiveness, showing it can manage cancer with minimal side effects. Overall, these findings suggest SABR could be a strong option for managing RCC with tumor thrombus, a clot of cancer cells in a vein. ^{2 6 7 8 9}

Who Is on the Research Team?

Raquibul Hannan, MD

Principal Investigator

UTSW

Are You a Good Fit for This Trial?

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

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

I agree to use birth control during the study.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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) 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10698523/

Stereotactic ablative radiotherapy for primary renal cell ... analyzed 81 patients from IROCK with solitary kidneys who underwent SAbR and found a 2-year local control rate of 98 %, with an associated mean ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2950393024001177

Stereotactic body radiation therapy for primary renal cell ... Studies report local control rates ranging from 70% to 100% with SABR, highlighting its efficacy in treating RCC. The decline in glomerular filtration rate (GFR) ...

3. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00656-8/abstract

5-year outcomes after stereotactic ablative body ... SABR is effective and safe in the long term for patients with primary renal cell carcinoma. Single-fraction SABR might yield less local failure ...

4. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00122-8/fulltext

Stereotactic Radiation Therapy for the Treatment of ... One-year overall survival was 82.2%, progression-free survival was 48.2%, and local control was 95.9%. Acute grade 2 and 3 toxicity related to SABR was 7.4%.

5. dailynews.ascopubs.org dailynews.ascopubs.org/do/stereotactic-ablative-radiotherapy-metastatic-renal-cell-carcinoma-disease-modifying

Is Stereotactic Ablative Radiotherapy for Metastatic Renal ... SABR has been shown to improve outcomes including overall survival (OS) for patients with oligometastatic cancers.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28587057/

Safety and Efficacy of Stereotactic Ablative Radiation Therapy ... SAbR demonstrated excellent LC of metastatic renal cell carcinoma with a favorable safety profile when an adequate dose and coverage were applied.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204524000202

Stereotactic ablative body radiotherapy for primary kidney ... Stereotactic ablative body radiotherapy (SABR) is a novel non-invasive alternative for patients with primary renal cell cancer who do not undergo surgical ...

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00138-5/fulltext

Dose-response of localized renal cell carcinoma after ... Safety and efficacy of stereotactic ablative radiation therapy for renal cell cancer: 24-month results of the RSR1 phase 1 dose escalation study.

9. actionkidneycancer.org actionkidneycancer.org/5-year-outcomes-after-sabr-for-primary-kidney-cancer/

5-year outcomes after SABR for primary kidney cancer SABR failure rate at 5 years was 5·5% overall. There were no serious side effects or treatment-related deaths. SABR is effective and safe in the long term.