NCT04071223|Active Not RecruitingPhase 2FDA Drug

Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, RadiCaL Study

A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients With Advanced Renal Cell Carcinoma With Bone Metastasis (RadiCal)

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2019-05619A031801U10CA180821

Study Type

interventional

Target

134

Locations

1 country

Sites

Timeline

RegisteredAug 2019

StartedJul 2020

CompletionOct 2026

Brief Summary

This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

134

participants targeted

Target at P75+ for phase_2

Timeline

3mo left

Started Jul 2020

Longer than P75 for phase_2

Geographic Reach

1 country

47 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.2 years study duration

Study Progress95%

Jul 2020Oct 2026

First Submitted

Initial submission to the registry

August 26, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed

11 months until next milestone

Study Start

First participant enrolled

July 29, 2020

Completed

6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 13, 2026

Status Verified

December 1, 2025

Enrollment Period

6.2 years

First QC Date

August 26, 2019

Last Update Submit

May 12, 2026

Conditions

Advanced Renal Cell Carcinoma Papillary Renal Cell Carcinoma Kidney Medullary Carcinoma Stage IV Renal Cell Cancer AJCC v8 Chromophobe Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma Metastatic Malignant Neoplasm in the Bone Collecting Duct Carcinoma Unclassified Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

Symptomatic skeletal event (SSE)-free survival (FS)
SSE-FS distribution will be estimated using the method of Kaplan-Meier by treatment arm. Comparison between the two arms will be performed using a one-sided log-rank test and one-sided p-value less than 0.025 will indicate that the experimental arm is superior to the control arm. SSE-FS will be censored at the date of last SSE assessment for those alive and SSE free. Hazard ratio (experimental over control arm) as well as two-sided 90% confidence interval (CI) for treatment will be estimated using the stratified Cox proportional hazard model with a single treatment covariate.
From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years

Secondary Outcomes (6)

Incidence of adverse events
Up to 5 years
SSE-FS
From randomization to the date of SSE or death due to any cause, whichever comes first, assessed up to 5 years
Progression-free survival
From randomization to time of radiographic progression or death due to any cause, whichever occurs first, assessed up to 5 years
Overall survival
From randomization to the date of death due to any cause, assessed up to 5 years
Time to first SSE
From randomization to the date of first SSE or death due to any cause, assessed up to 5 years
+1 more secondary outcomes

Study Arms (2)

Arm A (radium Ra 223 dichloride, cabozantinib s-malate)

EXPERIMENTAL

Patients receive radium Ra 223 dichloride IV over 1 minute on day 1 of cycles 1-6 and cabozantinib S-malate PO QD on days 1-28 of every cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection, bone scan, CT, or MRI, and may undergo FDG-PET or NaF-PET throughout the study.

Procedure: Biospecimen CollectionProcedure: Bone ScanDrug: Cabozantinib S-malateProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyOther: Questionnaire AdministrationRadiation: Radium Ra 223 Dichloride

Arm B (cabozantinib s-malate)

ACTIVE COMPARATOR

Patients receive cabozantinib S-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection, bone scan, CT, or MRI, and may undergo FDG-PET or NaF-PET throughout the study.

Interventions

Biospecimen CollectionPROCEDURE

Undergo blood and urine sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection