Interstitial Radiation Therapy for Kidney Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Non-renal malignancy, Uncontrolled illness, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating large kidney tumors using interstitial brachytherapy, also known as interstitial radiation therapy. This technique places a temporary radiation source directly into or near the tumor to shrink it, particularly for those unable to undergo surgery. The goal is to determine if this approach can effectively reduce tumor size and prevent its spread. Individuals with kidney cancer who cannot have surgery and have tumors that continue to grow despite other treatments might be suitable candidates. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

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, since the trial excludes those with prior systemic treatment for kidney cancer, you may need to discuss your current medications with the trial team.

What prior data suggests that interstitial brachytherapy is safe for treating kidney cancer?

Research has shown that interstitial brachytherapy, a type of internal radiation treatment, is generally safe for treating kidney cancer. Earlier studies reported no immediate harmful effects on kidney function or nearby organs, indicating that the treatment is well-tolerated in terms of radiation exposure.

Another study used a similar method with high-dose-rate brachytherapy and found it both safe and effective. Patients received a median dose over several sessions, and the treatment showed no major side effects.

These findings suggest that interstitial brachytherapy is a promising option for individuals with kidney cancer who cannot undergo surgery. However, like any treatment, there is always a risk of side effects. It is important to discuss these with a doctor before making a decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Interstitial Radiation Therapy is unique because it delivers radiation directly into the kidney tumor, minimizing exposure to surrounding healthy tissue. This direct delivery method differs from traditional external beam radiation, which can affect a broader area and potentially cause more side effects. Researchers are excited about this approach because it offers the potential for more precise targeting of cancer cells, leading to fewer side effects and possibly better outcomes for patients with kidney cancer. Additionally, the flexibility to administer treatment over one or two sessions provides a tailored approach to individual patient needs.

What evidence suggests that interstitial radiation therapy might be an effective treatment for kidney cancer?

Research shows that interstitial brachytherapy, a type of internal radiation treatment, effectively targets tumors by delivering high doses of radiation directly to cancer cells. Studies have found that this method can shrink kidney tumors while limiting harm to nearby healthy tissues. No immediate harmful effects on kidney function or nearby organs have been observed after this treatment. This trial will evaluate interstitial brachytherapy as a promising option for controlling and reducing the size of kidney cancer masses, particularly for those who cannot undergo surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Albert Chang, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with kidney cancer that's too large or unsuitable for surgery or ablation. They must not be candidates for curative surgery, have a tumor size of 4-10 cm without evidence of advanced disease, and have normal liver function tests. Women must test negative for pregnancy, and all participants need good blood counts and kidney function.

Inclusion Criteria

Your total bilirubin level is within the normal range.

I can do most of my daily activities without help.

My kidney cancer was confirmed through a biopsy.

Exclusion Criteria

I need urgent treatment for my kidney cancer due to bleeding, pain, or related symptoms.

I do not have any uncontrolled illnesses like infections or heart problems.

I have had surgery or radiation therapy at the site where I will have an operation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Interstitial Radiation Therapy

Trial Overview The study is testing interstitial brachytherapy—a type of internal radiation therapy—on patients with large kidney tumors that can't be removed surgically. The goal is to see if this treatment can limit tumor growth and potentially shrink the cancer enough to lower the risk of it spreading.

How Is the Trial Designed?

Group I: Treatment (interstitial brachytherapy) Experimental Treatment 1 Intervention

Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.

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

Approved in European Union as Brachytherapy for:

• Prostate cancer
• Breast cancer
• Cervical cancer
• Esophageal cancer
• Head and neck cancers
• Lung cancer
• Rectal cancer
• Soft tissue sarcomas
• Vaginal cancer
• Uterine (endometrial) cancer

Approved in United States as Brachytherapy for:

• Prostate cancer
• Breast cancer
• Cervical cancer
• Esophageal cancer
• Head and neck cancers
• Lung cancer
• Rectal cancer
• Soft tissue sarcomas
• Vaginal cancer
• Uterine (endometrial) cancer
• Kidney cancer

Approved in Canada as Brachytherapy for:

• Prostate cancer
• Breast cancer
• Cervical cancer
• Esophageal cancer
• Head and neck cancers
• Lung cancer
• Rectal cancer
• Soft tissue sarcomas
• Vaginal cancer
• Uterine (endometrial) cancer

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Published Research Related to This Trial

In a study of 14 patients with metastatic renal cell carcinoma (mRCC), image-guided high-dose-rate interstitial brachytherapy (iBT) achieved a remarkable local tumor control rate of 92.6% over a median follow-up of 10.2 months.

The treatment was found to be safe, with no severe adverse events reported, and resulted in a median overall survival of 51.2 months, indicating its potential as an effective option for patients with unresectable liver metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioablation of Hepatic Metastases from Renal Cell Carcinoma With Image-guided Interstitial Brachytherapy. Omari, J., Heinze, C., Damm, R., et al.[2019]

A new three-step protocol combining surgery with intraoperative radiotherapy (IORT) and an external boost of 40 Gy was tested on six patients with local recurrences of renal cell carcinoma, showing no increase in side effects or morbidity.

One year after treatment, there were no recurrences in the radiation field, suggesting that this protocol may be effective for patients with solitary local recurrences and advanced tumors (clinical stage T3 and T4).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intraoperative electron irradiation (IORT) of urologic tumors. Initial results of a pilot study of local recurrences of renal cell cancers]. Beer, M., Eble, MJ., Wannenmacher, M., et al.[2006]

In a study of 85 patients with metastatic renal cell carcinoma, the 2-year survival rate was 33% and the 5-year survival rate was 32%, with the best outcomes seen in patients with isolated skeletal metastases (69% at 2 years and 60% at 5 years).

The use of radioactive interstitial implants, particularly with iodine-125, not only reduced tumor burden but may also stimulate the immune response, leading to remission, although patients with CNS and other parenchymal metastases had poorer outcomes due to treatment limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of primary and metastatic renal cell carcinoma by transcatheter embolization with iodine 125. Lang, EK., Sullivan, J.[2019]

Intraoperative radiotherapy (IORT) combined with nephrectomy or rescue surgery in 11 patients with advanced renal carcinoma showed a high local tumor control rate of 82% at an average follow-up of 8 months, indicating its potential effectiveness in treating difficult cases.

No toxic effects or complications related to IORT were observed, suggesting that this treatment approach is safe for patients undergoing surgery for renal tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intraoperative radiotherapy in locally advanced carcinoma of the kidney: initial experience]. Santos, M., Ucar, A., Ramos, H., et al.[2006]

Out of 160 patients with renal cell carcinoma (RCC), 100 were treated with interventional radiology (IVR) techniques, primarily therapeutic arterial embolization or intraarterial infusion of anticancer drugs, during the late 1970s to late 1980s.

The study indicates that while IVR was used frequently in the early years, more recent treatments have shifted towards nephrectomies, and overall, IVR has shown greater effectiveness in treating hepatocellular carcinoma compared to RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of interventional radiology for renal cell carcinoma in 100 patients. Minakuchi, K., Takada, K., Nishio, H., et al.[2016]

In a study of 17 patients with locally recurrent renal cell carcinoma, the combination of intraoperative electron radiation therapy (IOERT) and external beam radiation therapy (EBRT) achieved a high local control rate of 91% over two years, despite many patients having unfavorable surgical outcomes.

The treatment resulted in a 73% overall survival rate, but progression-free survival was limited due to a high rate of distant failures, highlighting the need for more aggressive systemic treatments, especially for patients with higher tumor grades and shorter intervals between surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative electron radiation therapy (IOERT) in patients with locally recurrent renal cell carcinoma. Habl, G., Uhl, M., Hensley, F., et al.[2021]

Patients with advanced stage renal cell carcinoma treated with 125I interstitial infarct implants showed significantly improved survival rates, with 50% surviving at 2 years and 37% at 5 years.

The treatment, which involves transcatheter embolization, not only helps manage nonresectable tumors but may also enhance the host's immune response, making it a recommended option for patients who cannot undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter embolization of renal tumors with I-125 particles. Lang, EK.[2004]

Iodine-125 prostate seed brachytherapy shows high rates of biochemical control for prostate cancer in renal transplant recipients, with all four patients in the study remaining free of PSA progression after an average follow-up of 44 months.

The treatment demonstrated minimal toxicity, as there were no peri-operative complications and all patients maintained normal kidney function, suggesting it is a safe alternative to traditional surgery and radiotherapy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iodine-125 prostate seed brachytherapy in renal transplant recipients: an analysis of oncological outcomes and toxicity profile. Beydoun, N., Bucci, J., Malouf, D.[2021]

Interstitial brachytherapy is a modern and effective radiotherapy method that allows for high dose rate (HDR) treatment directly into tumor regions, improving success rates for localized tumors.

This technique is commonly used for various cancers, including breast, head and neck, and prostate tumors, and is enhanced by multidisciplinary management to improve patient outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of interstitial brachytherapy in multimodality management of solid tumors]. Soumarová, R., Homola, L., Perková, H., et al.[2016]

The ICRP Committee 3 is finalizing recommendations to prevent accidents in high-dose-rate brachytherapy, highlighting over 500 reported incidents and providing strategies to reduce their frequency and severity.

For prostate cancer brachytherapy using permanently implanted sources, while no severe accidents have been reported, the committee addresses radiation safety concerns related to patient dose, migrating seeds, and cremation, offering specific recommendations to mitigate these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The recommendations of the International Commission on Radiological Protection (ICRP) for high-dose-rate brachytherapy and for permanent prostatic implants]. Cosset, JM., Pinillos-Ashton, L., Mettler, F.[2013]

In a pilot trial involving 16 patients with renal masses, CT-guided high-dose-rate brachytherapy (HDR-BT) demonstrated a high local control rate of 95% for tumors, indicating its effectiveness as a local ablative treatment.

The treatment was found to be safe, with only one patient requiring permanent hemodialysis and no significant worsening of renal function or major side effects observed in the other patients during a median follow-up of 22.5 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of CT-guided HDR brachytherapy as a local ablative treatment for renal masses: a single-arm pilot trial. Damm, R., Streitparth, T., Hass, P., et al.[2020]

High-dose-rate interstitial brachytherapy (iBT) for liver tumors shows a low major complication rate of less than 5%, with only 1.5% experiencing major bleeding, particularly in patients with advanced liver cirrhosis.

The treatment is effective, with a median overall survival of 20.1 months and an 89% local recurrence-free rate after 12 months, indicating its potential as a safe and effective option for patients with liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioablation of liver malignancies with interstitial high-dose-rate brachytherapy : Complications and risk factors. Mohnike, K., Wolf, S., Damm, R., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04473781

Interstitial Brachytherapy for the Treatment of Unresectable ... This phase I/II trial investigates the side effects of interstitial brachytherapy and to see how well it works in limiting the growth of large kidney cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9924155/

Radiation exposure to the kidney with interstitial iridium ... There were no acute radiation-induced effects on the renal function or adjacent organs to the treatment location immediately after treatment with HDR-BT. The ...

3. kidneycancer.org kidneycancer.org/trial/interstitial-brachytherapy-for-the-treatment-of-unresectable-unablatable-kidney-cancer/

Interstitial Brachytherapy for the Treatment of Unresectable ... This phase I/II trial investigates the side effects of interstitial brachytherapy and to see how well it works in limiting the growth of large kidney cancer ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-04542

Interstitial Brachytherapy for the Treatment of Unresectable ... This phase I/II trial investigates the side effects of interstitial brachytherapy and to see how well it works in limiting the growth of large kidney cancer ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10863227/

Review of brachytherapy clinical trials - PubMed Central - NIH The ability of brachytherapy to accurately deliver very high doses of radiation to the tumor while sparing surrounding tissues to minimize ...

6. e-roj.org e-roj.org/journal/view.php?number=1635

Technique and outcomes of high-dose-rate interstitial ... Our approach of delivering a median dose of 40 Gy in 10 fractions of brachytherapy twice daily, has shown to be a safe and effective treatment ...

7. mdpi.com mdpi.com/2077-0383/13/24/7550

Interstitial High-Dose-Rate Brachytherapy Combined with ... The overall clinical response rate was 83.33% with five out of six patients achieving local control, while one out of six (16.66%) showed local and general ...