Study on Adding Radium-223 to Usual Treatment for Advanced Kidney Cancer Spread to the Bone

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04071223

Provider View

This clinical trial is exploring whether adding a new drug, radium-223, to the usual treatment with cabozantinib can improve outcomes for patients with advanced kidney cancer that has spread to the bones. Radium-223 is a radioactive drug that targets cancer cells, while cabozantinib blocks enzymes that help cancer grow. The study aims to see if this combination can better manage pain and symptoms compared to cabozantinib alone.

Patient Parameters

Program Overview

This study is testing if adding radium-223, a radioactive drug, to the usual treatment with cabozantinib can help patients with advanced kidney cancer that has spread to the bones. Radium-223 targets cancer cells with radiation, while cabozantinib works by blocking certain enzymes needed for cancer growth. The goal is to see if this combination can reduce pain and symptoms more effectively than cabozantinib alone.

Description

The main goal of this study is to see if the combination of cabozantinib and radium-223 can help patients with advanced kidney cancer that has spread to the bones live longer without bone-related problems, compared to cabozantinib alone. Researchers will also look at the safety and side effects of the combination treatment.

Other goals include:

  • Checking how long patients live without the cancer getting worse.
  • Measuring overall survival rates.
  • Evaluating the time until the first bone-related problem occurs.
  • Assessing the response of the cancer to the treatment.
  • Comparing the quality of life and pain levels reported by patients.

The study will also explore changes in bone markers and immune responses, and look for genetic markers that might predict how well patients respond to the treatment.

Participants will be randomly assigned to one of two groups:

  • Group A will receive radium-223 and cabozantinib.
  • Group B will receive cabozantinib alone.

Both groups will have regular blood tests, scans, and possibly other imaging tests throughout the study. After finishing the treatment, patients will be followed up every six months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of kidney cancer, including various subtypes.
  • Must have at least one bone metastasis that hasn't been treated with radiation.
  • No previous treatment with cabozantinib or similar drugs.
  • No major surgery within six weeks before starting the study.
  • Must be 18 years or older.
  • Must have a good performance status, meaning able to carry out daily activities with minimal assistance.
  • Must not have untreated brain metastases or spinal cord compression.
  • Must not have significant, uncontrolled health issues, such as heart problems or active infections.
  • Women must not be pregnant or breastfeeding and must use effective birth control.
  • Must have adequate blood counts and organ function as determined by specific tests.

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