Study Comparing Focused Radiation and Standard Therapy for Kidney Cancer with Limited Spread (SOAR Study)

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05863351

Provider View

This clinical trial is exploring whether adding focused radiation therapy to the usual treatment can improve outcomes for patients with kidney cancer that has spread to a few places in the body. The study aims to see if this approach is better than the standard treatment alone.

Patient Parameters

Program Overview

This study is testing if using focused radiation therapy, called SAbR, along with standard treatment, can help control kidney cancer that has spread to a limited number of places in the body. The standard treatment usually involves medications given through the veins or as tablets. SAbR uses precise radiation to target tumors, and researchers want to see if adding it before the usual treatment can kill more cancer cells than the standard treatment alone.

Description

The main goals of this study are to compare the overall survival of patients receiving focused radiation therapy plus standard treatment to those receiving only the standard treatment. Researchers will also look at the side effects and quality of life for patients in both groups.

Secondary goals include comparing how long patients live without the cancer getting worse and evaluating the cost-effectiveness of the treatments. The study will also assess changes in patients' quality of life over time.

Participants will be randomly assigned to one of two groups. One group will receive the standard treatment, while the other group will receive focused radiation therapy followed by the standard treatment. Both groups will have regular scans to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of kidney cancer.
  • Must not have a type of kidney cancer with a sarcomatoid component.
  • Must have had the primary tumor treated locally if still present.
  • Must have a favorable or intermediate risk score for metastatic kidney cancer.
  • Must have 2 to 5 metastatic lesions as confirmed by recent imaging.
  • Must have confirmation from a radiation oncologist that all sites can be treated with SAbR.
  • May have had previous therapy in the adjuvant setting if fully recovered.
  • Must not have other cancers that interfere with the study treatment.
  • Must have a good heart health assessment if there is a history of heart disease.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Must be able to understand and sign a consent form, or have a representative to do so.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have adequate organ and bone marrow function as determined by the treating doctor.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Patients with controlled hepatitis B or cured hepatitis C are eligible.
  • Must speak a language in which the quality of life assessments are available.

Exclusion Criteria

  • Must not have cancer that has spread to the brain.
  • Must not have cancer spread to certain critical areas like the central lung or digestive tract.
  • Must not have received prior systemic therapy for metastatic kidney cancer, except in the adjuvant setting.
  • Must not have active autoimmune disease requiring ongoing treatment.
  • Must not have severe allergies to certain antibodies.
  • Must not have active tuberculosis.
  • Must not have uncontrolled high blood pressure.
  • Must not have had major surgery within 30 days before starting the study.
  • Must not have serious non-healing wounds or fractures.
  • Must not have had recent major heart or blood vessel events.
  • Must not have severe liver impairment.
  • Must not have untreated blood clots in the lungs or legs.
  • Must not have unstable heart rhythms.
  • Must not have certain digestive system issues.
  • Must not be pregnant or breastfeeding.
  • Must agree to use effective contraception during the study and for 6 months after.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.