~1 spots leftby Jun 2025

Interstitial Radiation Therapy for Kidney Cancer

Palo Alto (17 mi)
Overseen byAlbert Chang, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo Group
Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This trial studies the effects of a treatment that places a small radiation source directly inside or near large kidney cancer masses in patients who cannot have surgery. The treatment aims to shrink the tumor and prevent it from spreading. This approach has been shown to provide high tumor control rates in various types of cancer.
Is Interstitial Radiation Therapy a promising treatment for kidney cancer?Yes, Interstitial Radiation Therapy, also known as Brachytherapy, is a promising treatment for kidney cancer. It has shown high tumor control rates and can be used to treat both primary and metastatic kidney cancer. This treatment can help reduce tumor size and may boost the body's immune response, potentially leading to remission. It is also a fast and relatively inexpensive method that can be combined with other treatments to improve success rates.234711
What safety data exists for interstitial radiation therapy for kidney cancer?The safety of interstitial radiation therapy, also known as brachytherapy, has been evaluated in various studies. A pilot trial investigated the safety of CT-guided high-dose-rate brachytherapy as a local treatment for renal masses, indicating its potential as a safe option for patients not eligible for surgery. Additionally, the International Commission on Radiological Protection has provided recommendations to prevent accidents in high-dose-rate brachytherapy, highlighting the importance of safety measures. While specific data on kidney cancer is limited, these studies and guidelines suggest a focus on minimizing risks and managing complications in brachytherapy applications.69101112
What data supports the idea that Interstitial Radiation Therapy for Kidney Cancer is an effective treatment?The available research shows that Interstitial Radiation Therapy, specifically intraoperative radiotherapy (IORT), has shown promising results in controlling kidney cancer. One study reported that after using IORT in patients with locally advanced kidney cancer, 82% of the patients had their tumors controlled locally after an average follow-up of 8 months, without an increase in side effects. This suggests that IORT can be effective in managing kidney cancer, especially when combined with surgery. However, it's important to note that other treatments like interventional radiology have been less effective for kidney cancer compared to other types of cancer.125811
Do I have to stop taking my current medications for the trial?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.

Eligibility Criteria

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

I can do most of my daily activities without help.
My cancer has not spread to nearby lymph nodes or distant parts of my body.
I am a woman who can have children and my pregnancy test before starting therapy was negative.
My cancer can be treated with brachytherapy according to my radiation oncologist.
I cannot or do not want to have surgery to cure my condition.
I have not received any systemic treatment for kidney cancer.
My tumor is mostly solid.
My kidney cancer was confirmed through a biopsy.
My kidney tumor can be treated with a special type of radiation.
I have chosen to receive internal radiation therapy for my kidney cancer.
My cancer cannot be treated with targeted destruction methods.
My tumor is between 4 and 10 cm in size.
My lesion has been growing for over 6 months and is expected to grow more than 4mm a year.

Exclusion Criteria

I have had surgery or radiation therapy at the site where I will have an operation.
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 an untreated cancer that is not kidney cancer.
I have a history of unusual bleeding or had a recent bleeding episode.

Treatment Details

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.
1Treatment groups
Experimental Treatment
Group I: Treatment (interstitial brachytherapy)Experimental Treatment1 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

Find a clinic near you

Research locations nearbySelect from list below to view details:
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
Loading ...

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

References

Clinical evaluation of interventional radiology for renal cell carcinoma in 100 patients. [2016]One hundred of 160 patients with renal cell carcinoma (RCC) were treated by interventional radiology (IVR) in the period from 1978 to 1989. The number and kind of interventions done each year were classified retrospectively. More than half of the patients underwent therapeutic arterial embolization or intraarterial infusion of anticancer drugs during the first half of the period. More recently, about half of the patients have had nephrectomies without IVR. One patient with advanced RCC by IVR 18 times lived 8 years and three months after diagnosis, but that was exceptionally long. IVR has been more effective against hepatocellular carcinoma than RCC, for several reasons.
[Intraoperative radiotherapy in locally advanced carcinoma of the kidney: initial experience]. [2006]Intraoperative radiotherapy (IORT) is a rather interesting therapeutic modality in multidisciplinary oncology. Its greatest advantages reside in the approach of deeply seeded abdomino-pelvic tumors. Its inclusion in the therapeutic approach of renal carcinoma with a high local relapse rate has been analyzed in this study in relation to its technical aspects and preliminary clinical results. 11 stage III or IV patients or with local relapse in lumbar fossa were treated with nephrectomy or exeresis surgery and OIRT (10-20 Gy). Surgical exposure of the lumbar fossa and nodal drainage areas was appropriate in dal cases. No toxic signs or sequellae relating to OIRT were observed. Local tumor controls at 8 months of follow-up on the average (range from 2 to 33 months), was 82%. The data obtained in this series suggest the viability of the combined approach nephrectomy or rescue surgery and IORT. The initial clinical results suggest HIGH local tumor control without an increase in the toxicity rate or complications.
Management of primary and metastatic renal cell carcinoma by transcatheter embolization with iodine 125. [2019]The long-term results of the management of metastatic renal cell carcinoma by a radioactive interstitial implant seated by a transcatheter embolization technique were evaluated in 85 patients at risk at 2 years and 37 at 5 years. The 2-year survival rate was 33% and the 5-year survival rate was 32%. Patients with isolated skeletal metastases showed the best survival rate (2-year survival rate, 69%; 5-year survival rate, 60%). Isolated pulmonary, other parenchymal, and central nervous system (CNS) metastases showed a lower 2-year survival rate of 15%. Regardless of the site of metastases and the size of the primary, histologic grade appeared to have a substantial impact on the survival of our patients. The beneficial results of interstitial radiation therapy are attributed to reduction of tumor burden and possibly the stimulation of the host immune response that may initiate remission. The noticeably better results in patients with osseous metastases are attributed to the resolute treatment of all osseous metastases by additional interstitial iodine 125 (125I) infarct implants. Conversely, the poor results in patients with CNS and other parenchymal metastases may be based on the inability to treat such metastases with 125I interstitial infarct implants. In addition to clinical observations of weight gain and the cessation of pain and hematuria if present, remissions are heralded by normalization of the erythrocyte sedimentation rate, disappearance of tumor markers if present, and rise of beta interferon levels. The technique is advocated for the management of inoperable renal cell carcinoma with distant metastases.
Transcatheter embolization of renal tumors with I-125 particles. [2004]Remarkably improved survival rates are reported in patients treated for advanced stage renal cell carcinoma by 125I interstitial infarct implant (2y = 50%, 5y = 37% survival). The interstitial implants are seated by transcatheter embolization. The salutory results particularly in patients treated for advanced stage primary lesions and bone metastases suggest the added impact of improved host immune response. The method is recommended for the management of nonresectable neoplasms, neoplasms in a solitary kidney, in patients with medical contraindications to surgical management and to convert unresectable neoplasms into resectable ones.
[Intraoperative electron irradiation (IORT) of urologic tumors. Initial results of a pilot study of local recurrences of renal cell cancers]. [2006]The efficacy of radiotherapy of renal cell carcinomas is limited by its side effects. To avoid gastrointestinal problems the dose must not exceed 45 Gy, but with corresponding protocols no effect has been seen in curative and adjuvant trials. A new three-step protocol combining surgery with intraoperative radiotherapy focussed on the tumor bed fading out the intestine (IORT) and external boost radiotherapy (40 Gy) was used in six patients with local recurrences after tumor nephrectomy. No increase in morbidity was induced by IORT. One year after radiotherapy no recurrences have been seen in the radiation field. We recommend this protocol for patients with solitary local recurrences and for tumors of clinical stage T3 and T4.
[The recommendations of the International Commission on Radiological Protection (ICRP) for high-dose-rate brachytherapy and for permanent prostatic implants]. [2013]ICRP (International Commission for Radiological Protection) Committee 3 ("Radioprotection in medicine") is currently finalizing two recommendations about Brachytherapy. The first text, from Task Group (TG) 53, is focussing on the prevention of high-dose-rate brachytherapy accidents. It reminds the reader of the 500 accidents/incidents which have been reported so far in the literature, and reports in details on some representative accidents. Building on those data, the text gives general and specific recommendations, aiming at reducing both the frequency and the severity of those accidents. The second text, from Task Group 57, considers the radiation safety aspects of brachytherapy for prostate cancer using permanently implanted sources. For this topic, no severe accident has never been reported so far. However, some radioprotection problems arose, due to the dose received from the patients, to migrating seeds and to cremation. The text presents recommendations specifically addressing those issues.
7.Czech Republicpubmed.ncbi.nlm.nih.gov
[The role of interstitial brachytherapy in multimodality management of solid tumors]. [2016]Although being used for several decades, interstitial brachytherapy remains a modern radiotherapeutic method. Over the time, it has been highly improved, including the latest technologies. Its broad use has been facilitaed by the use of high dose rate (HDR) afterloadings. The method is fast and fairly inexpensive. Its prons include, in particular, a possibility to apply a dose, in addition to external radiotherapy, directly into the tumor region or its focus, which may improve treatment success rates in patients with localized tumors. The commonest diagnoses, where interstitial brachytherapy is employed, include the following: breast carcinomas, soft tissue sarcomas, head and neck tumors, gynaecological tumors, penile and anal tumors and prostate tumors. In the article, the authors aimed to highlight potential and benefits of intersitital brachytherapy in individaual diagnoses. Only multidisciplinary management of these patients may improve their prognosis or quality of life.
Intraoperative electron radiation therapy (IOERT) in patients with locally recurrent renal cell carcinoma. [2021]To analyze our experience with intraoperative electron radiation therapy (IOERT) followed by moderate doses of external beam radiation therapy (EBRT) in patients with locally recurrent renal cell carcinoma.
Iodine-125 prostate seed brachytherapy in renal transplant recipients: an analysis of oncological outcomes and toxicity profile. [2021]Prostate cancer is among the most common non-cutaneous neoplasms affecting renal transplant recipients (RTRs). Available treatments including radical prostatectomy and external beam radiotherapy carry a risk of damage to the transplanted kidney, ureters, or bladder. We assessed the safety and efficacy of Iodine-125 ((125)I) prostate seed brachytherapy as an alternative to surgery and radiotherapy in these individuals.
Radioablation of liver malignancies with interstitial high-dose-rate brachytherapy : Complications and risk factors. [2022]To evaluate complications and identify risk factors for adverse events in patients undergoing high-dose-rate interstitial brachytherapy (iBT).
Radioablation of Hepatic Metastases from Renal Cell Carcinoma With Image-guided Interstitial Brachytherapy. [2019]High-dose-rate interstitial brachytherapy (iBT) has been shown to provide high tumor control rates in the treatment of primary or secondary malignancies at various sites. The objective of this study was to evaluate the efficacy and safety of image-guided iBT in patients with metastatic renal cell carcinoma (mRCC).
Prospective evaluation of CT-guided HDR brachytherapy as a local ablative treatment for renal masses: a single-arm pilot trial. [2020]In this pilot trial, we investigate the safety of CT-guided high-dose-rate brachytherapy (HDR-BT) as a local ablative treatment for renal masses not eligible for resection or nephrectomy.