Study on Pre-Surgery Radiation Therapy for Kidney Cancer with Tumor in the Vena Cava

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT02473536

Provider View

This clinical trial is testing if a special type of radiation therapy, given before surgery, can safely and effectively treat kidney cancer that has spread to the vena cava, a large vein. The study aims to see if this approach can help prevent the cancer from coming back within a year.

Patient Parameters

Program Overview

The study is exploring the use of Stereotactic Ablative Radiation Therapy (SABR) before surgery to treat kidney cancer that has spread to the vena cava, a major vein. SABR involves delivering precise, high-dose radiation to the tumor, aiming to destroy it while sparing nearby healthy tissue. Researchers want to see if this treatment can reduce the chances of the cancer returning and lower the risk of complications from the cancer spreading.

Description

This study involves using a type of radiation therapy called Stereotactic Ablative Radiation Therapy (SABR) to treat kidney cancer that has spread to the vena cava, a large vein that carries blood to the heart. SABR delivers high doses of radiation in a very targeted way, aiming to destroy the tumor while protecting surrounding healthy tissue. The treatment consists of either 5 sessions of 8 Gy or 3 sessions of 12 Gy. The goal is to see if this approach can reduce the risk of the cancer coming back and prevent complications from the cancer spreading. This type of radiation therapy has been used successfully for brain tumors, and researchers are now testing its effectiveness for kidney cancer with vena cava involvement.

Eligibility Criteria

Inclusion Criteria

  • Evidence of kidney cancer with a tumor in the vena cava, confirmed by imaging tests.
  • The tumor in the vena cava must be at least level II, according to specific medical guidelines.
  • Eligible for the SABR treatment as determined by a radiation oncologist.
  • Eligible for surgery to remove the tumor in the vena cava as determined by a urologist.
  • Any number of cancer spread is allowed in the initial phase of the trial. In later phases, all sites of cancer spread must be treated surgically or with radiation.
  • Age 18 years or older.
  • General health status allowing for normal activity or some restriction in strenuous activity (ECOG performance status 0-2).
  • Any level of serum albumin is allowed, but levels of 3.4 g/dL or higher are encouraged.
  • Any level of serum AST is allowed, but levels of 34 IU/L or lower are encouraged.
  • Women of childbearing potential and men must agree to use effective birth control during the study and for 90 days after completing radiation therapy.
  • Ability to understand and sign a written informed consent.
  • Must be able to undergo MRI or CT scans.

Exclusion Criteria

  • Previous radiation treatment to an area within 3 cm of the vena cava tumor.
  • Previous treatment with investigational drugs or chemotherapy is allowed if eligible for SABR and surgery.
  • Brain metastases are excluded unless all are treated surgically or with radiation.
  • History of blood clots in the lungs (pulmonary embolism) is excluded.
  • History of high blood pressure in the lungs (pulmonary hypertension) is excluded.
  • Pregnant women are excluded due to potential risks to the unborn baby.
  • Unable to undergo MRI due to medical conditions or metal implants, but can participate if eligible for CT scans.

Locations

FACILITYZIPCITYSTATE
University of Texas Southwestern Medical Center75239DallasTexas

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