Study on Internal Radiation Therapy for Treating Large Kidney Tumors That Cannot Be Removed or Treated with Heat

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04473781

Provider View

This clinical trial is exploring the use of internal radiation therapy, known as brachytherapy, to treat large kidney tumors in patients who cannot or choose not to have surgery or heat treatment. The study aims to see if this method can safely reduce tumor size and prevent cancer from spreading.

Patient Parameters

Program Overview

This study is testing a treatment called interstitial brachytherapy, which involves placing a temporary radiation source inside or near a kidney tumor to kill cancer cells. The goal is to see if this treatment can safely shrink large kidney tumors in patients who cannot have surgery or heat treatment. By reducing the tumor size, the treatment may lower the risk of the cancer spreading.

Description

The study has two main goals: first, to determine if interstitial brachytherapy is safe and feasible for treating kidney tumors, and second, to see how well it controls the tumor's growth.

Secondary goals include assessing how the tumor responds to treatment, monitoring if the cancer spreads within 12 months, and measuring the tumor's growth over a year. Researchers will also look for markers that predict how well the tumor responds to radiation.

Participants will receive 1-2 sessions of brachytherapy, depending on their condition. If two sessions are needed, they may occur on the same day or over two weeks. After treatment, patients will have follow-up visits every three months for at least three years to monitor their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Chosen to receive brachytherapy as part of standard treatment for kidney cancer.
  • Confirmed diagnosis of kidney cancer through a biopsy.
  • No signs of cancer spreading to nearby lymph nodes or distant organs.
  • Tumor size between 4 to 10 cm.
  • Not a candidate for surgery due to personal choice or medical reasons.
  • Tumor cannot be effectively treated with heat-based methods.
  • Tumor can be adequately treated with brachytherapy according to a radiation specialist.
  • Tumor is mostly solid (about 80% or more).
  • Tumor has been growing at a rate of at least 4 mm per year over the past 6 months.
  • Tumor can be accessed through the skin for brachytherapy.
  • Blood tests show adequate levels of hemoglobin, neutrophils, and platelets.
  • Liver function tests within normal limits.
  • Healthy immune system.
  • Kidney function is adequate (eGFR of 30 or higher).
  • Good overall health status (ECOG score less than 2).
  • Willing to provide informed consent.
  • No previous systemic treatment for kidney cancer.
  • Women of childbearing age must have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Have another active, untreated cancer.
  • Have uncontrolled medical conditions like infections, high blood pressure, irregular heartbeats, heart failure, or recent heart attack.
  • History of bleeding disorders or recent bleeding incidents.
  • Need urgent treatment for kidney cancer due to bleeding, pain, or related symptoms.
  • Have had previous surgery or radiation in the area to be treated.
  • Unwilling to participate in required monitoring and imaging studies.

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