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New treatment option for Renal Cell Carcinoma (RCC)
Official title Ablative Radioembolization of Renal Cell Carcinoma Trial
ClinicalTrials.gov ID: NCT06642220
What this study is testing
- What it's testing
- Renal cell carcinoma (RCC), the most common type of kidney cancer, is typically treated with surgery; however, there is no established therapy for patients who are not surgical candidates and who have tumours greater than 4.0 cm in size. Selective internal radiation therapy (SIRT) or radioembolization using radioactive spheres containing 90-Yttrium (Y-90) is successful at treating large tumours with high doses of radiation within the liver and might be similarly effective for treating larger RCC tumours in patients, particularly those who are not surgical candidates.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients willing to participate and provide written consent
- Patients 18 years of age and older
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
- Biopsy confirmed RCC \> 4.0 cm and no renal vein or IVC involvement (T1b or T2 disease)
- Not suitable for or declining standard of care nephrectomy or partial nephrectomy
You likely can't join if
- Evidence of metastatic disease on CT or MRI
- Severely impaired renal function (GFR ≤ 30 mL/min/1.73m²) and not on dialysis
- Bilateral RCC without plan for definitive therapy of the contralateral lesion
- RCC that is locally recurrent at prior surgery or ablation site (new location in same or contralateral kidney is permitted)
- Prior or concurrent kidney radiation therapy or systemic immunotherapy/TKI
- Lung shunt with estimated lung radiation dose \> 30 Gy for single dose or \> 50 Gy total.
See the full eligibility criteria
Who can join
- Patients willing to participate and provide written consent
- Patients 18 years of age and older
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
- Biopsy confirmed RCC \> 4.0 cm and no renal vein or IVC involvement (T1b or T2 disease)
- Not suitable for or declining standard of care nephrectomy or partial nephrectomy
- Adequate hepatic function, defined by the following laboratory results:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) (or ≤5 × ULN if presence of liver metastases)
- Total bilirubin ≤3 × ULN
- Serum albumin ≥3.0 g/dL unless prothrombin time (PT) is within the normal range
- Adequate hematologic function, defined by the following laboratory results:
- Hemoglobin concentration ≥8.0 g/dL
- Absolute neutrophil count (ANC) ≥1000 cells/µL (≥1000 cells/mm3 )
- Platelets \>50 × 109 /L (100 × 103 /mm3 )
- For women of childbearing potential (WOCBP):
- Negative serum pregnancy test within 48 hours prior to the first dose of study treatment
- Agreement to use barrier contraception and a second form of highly effective contraception (Clinical Trials Facilitation Group [CTFG] 2020) while receiving study treatment and for 7 months following their last dose of...
- Sexually active male people must use a condom during intercourse while receiving treatment and for at least 120 days after the last dose of the study treatment and should not father a child during this period.
- Male study people whose sexual partners are WOCBP must also agree to use a second form of highly effective contraception (CTFG 2020) while receiving 90Y and for at least 4 months following their last dose...
- Vasectomized men are also required to use a condom during intercourse, including with a male partner, to prevent delivery of the drug via seminal fluid.
What rules you out
- Evidence of metastatic disease on CT or MRI
- Severely impaired renal function (GFR ≤ 30 mL/min/1.73m²) and not on dialysis
- Bilateral RCC without plan for definitive therapy of the contralateral lesion
- RCC that is locally recurrent at prior surgery or ablation site (new location in same or contralateral kidney is permitted)
- Prior or concurrent kidney radiation therapy or systemic immunotherapy/TKI
- Lung shunt with estimated lung radiation dose \> 30 Gy for single dose or \> 50 Gy total.
- Planning angiogram cone beam CT from all accessible feeding arteries shows lack of perfusion to all or portions of the RCC tumour such that, in the investigator's opinion, Y-90 radioembolization would result in...
- Contraindication to arterial renal angiogram, or both CT and MRI contrast medium
- History of severe allergy to CT contrast medium or any study product ingredients that cannot be managed medically
- History of chronic lung disease with baseline oxygen saturation \< 90% or requiring home oxygen therapy.
- Congestive heart failure with ejection fraction \< 40%
- Presence of active infection, defined by the investigator as clinically significant.
- Any chronic condition that is severe or unstable and, in the opinion of the investigator, would put the patient at unacceptable risk of adverse event related to the Y-90 radioembolization procedure. Such conditions...
- Life expectancy \> 1 year
- Pregnant or breast-feeding patient
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.