Stereotactive body radiation therapy for Small Renal Masses (SRM)

Phase-Based Estimates
1
Effectiveness
1
Safety
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton, Hamilton, Canada
Stereotactive body radiation therapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Small Renal Masses (SRM)

Study Summary

This study is evaluating whether radiofrequency ablation (RFA) is as effective as stereotactic body radiation therapy (SBRT) in the treatment of small renal masses (SRMs).

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Stereotactive body radiation therapy will improve 4 primary outcomes and 9 secondary outcomes in patients with Small Renal Masses (SRM). Measurement will happen over the course of Days.

12 Months
Change in score for quality of life
Complication Rate
Cost analysis
Disease free survival
Disease recurrence
Number of patients that experienced an adverse event.
Overall Survival
Renal Function - Creatinine Clearance
Renal Function - Serum Creatinine
Renal Function -eGFR
Treatment failure
Tumour Size
Days
Duration of hospital stay

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Radiofrequency Ablation (RFA)
Stereotactic body radiation therapy (SBRT)

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stereotactive Body Radiation Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Stereotactic body radiation therapy (SBRT)
Radiation
Radiofrequency Ablation (RFA)
Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Who is running the study

Principal Investigator
A. K.
Anil Kapoor, Principal Investigator
St. Joseph's Healthcare Hamilton

Closest Location

McMaster Institute of Urology - St. Joseph's Healthcare Hamilton - Hamilton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients ≥18 years of age and capable of providing informed consent
Patients scheduled for treatment of their SRM using SBRT or RFA
Patients who received a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
Patients who are willing to have a biopsy 12 months post-procedure
Patients with renal tumor(s) ≤ 4.0 cm

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes small renal masses (srm)?

Add answer

The main aetiology of smRMs is an exogenous cause in the form of radiation exposure. Other aetiologies include the presence of malignant tumour, benign tumour including oncocytoma, cystic nephroma, and papillary variant of clear cell carcinoma. However, for smRMs associated with benign tumour or oncocytoma, these neoplasms account for less than 10% of all smRMs.

Unverified Answer

What are the signs of small renal masses (srm)?

Add answer

Patients with smr may present with an abdominal mass or blood in the urine suggestive of renal cancer. Patients presenting with urinary frequency, pain, flank tenderness and weight loss should obtain a CT scan and, if this is negative, repeat CT-scan imaging at subsequent intervals while retaining urine output in the physiologic range and followup with imaging every few months.

Unverified Answer

What is small renal masses (srm)?

Add answer

A patient that has an srm is generally asymptomatic with no evidence of malignancy. They are typically hydronephrotic with a urinary tract ultrasound demonstrating cysts with a variable amount of fluid. In general, they are not associated with other disease.

Unverified Answer

How many people get small renal masses (srm) a year in the United States?

Add answer

Around 5 million new cases of small renal masses is seen annually in the U.S. This accounts for 32% of new cases seen for solid masses by radiologists across all specialties.

Unverified Answer

What are common treatments for small renal masses (srm)?

Add answer

The most common treatments for patients with SRMs, according to our multi-institutional cohort, are a total of 12.8%, 4.4% with [RFA/SURG technique] and 16.7% with SWL. Based on our results, the most commonly used treatments for patients have not yet been tested in large, controlled clinical trials.

Unverified Answer

Can small renal masses (srm) be cured?

Add answer

With the recent advancements in pre-operative imaging, and the advent of minimally invasive surgery techniques, the risk of malignancy in srm has reduced dramatically. Patients with srm, who are not older than 90 years, can also expect to be cured with a positive prognosis.

Unverified Answer

Who should consider clinical trials for small renal masses (srm)?

Add answer

In our series, clinical trials were indicated for 44% of the smRMs. The patients who would benefit from trials tend to be older patients, patients living in the North of England and those of female gender. The selection criteria for clinical trial candidates for smRMs are not well characterized.

Unverified Answer

How does stereotactive body radiation therapy work?

Add answer

The body radiation of the SBRT is more effective on the tumor than on the normal tissue. The more and longer the treatment, the better the result.

Unverified Answer

How serious can small renal masses (srm) be?

Add answer

The majority of SRMs are malignant. The overall incidence of malignancy is 14% in SRMs<4 cm in diameter. However, in patients>60 yr of age, SRMs<4 cm are not associated with worse clinical outcomes.

Unverified Answer

Is stereotactive body radiation therapy typically used in combination with any other treatments?

Add answer

Stereotactic body radiation (SBRT) is the preferred option at the authors' institution. The data, including the most recent meta-analyses, suggest that there is similar disease control with SBRT as RTR plus chemotherapy. Additionally, studies have found that SBRT is less harmful to nontumorous organs compared with RTR plus chemotherapy. The authors recommend SBRT with chemoradiation in the setting of patients with multiple myeloma and kidney tumors.

Unverified Answer

What is stereotactive body radiation therapy?

Add answer

Stereotactic body radiation therapy (SBRT) for smRMs is an effective and safe treatment with excellent disease control rate. As local recurrence rate is high (up to 50%) compared to other modalities, these patients warrant more conservative treatment options.

Unverified Answer

What is the average age someone gets small renal masses (srm)?

Add answer

Results from a recent clinical trial shows that most small renal masses (srm) were found in patients of middle age. A significant number were found between the age range of 31 and 49. On average, they were found in patients who were about 40 years old.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Small Renal Masses (SRM) by sharing your contact details with the study coordinator.