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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and urine sample collection
• Bone Scan — PROCEDURE
  Undergo bone scan
• Cabozantinib S-malate — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo FDG-PET or NaF-PET
• Questionnaire Administration — OTHER
  Ancillary studies
• Radium Ra 223 Dichloride — RADIATION
  Given IV

Study Details

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.

Key Dates

Start date

Jul 29, 2020

Status verified

Jun 2026

Primary completion

Oct 1, 2026

Completion

Oct 1, 2026

Study Design

Enrollment

134 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (radium Ra 223 dichloride, cabozantinib s-malate)
  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.
• Active Comparator: Arm B (cabozantinib s-malate)
  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.

Primary Outcome Measure

Symptomatic skeletal event (SSE)-free survival (FS) [ Time Frame: From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years ]

Locations (47)

Find similar trials in Birmingham, AL

Related Studies

• Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma
  Recruiting · University of Southern California · Duarte, California
• Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
  Recruiting · University of Washington · Baltimore, Maryland
• Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
  PHASE3 · Recruiting · SWOG Cancer Research Network · Birmingham, Alabama