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Radiation

SABR for Kidney Cancer

Phase 2

Waitlist Available

Led By Raquibul Hannan, MD, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Metastatic renal cell carcinoma with limited measurable extracranial metastases (Limited metastases, or oligometastases, defined as ≤3 sites of metastasis)

Age ≥ 18 years

Must not have

Subjects with brain metastasis as assessed by contrast MRI or contrast CT scans(contrast recommended)

Subjects with previous history of brain metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a certain kind of radiation can help extend the amount of time patients with a certain kind of kidney cancer live without their disease getting worse, and whether it can delay the need for systemic therapy.

Who is the study for?

This trial is for adults with kidney cancer that has spread to up to three other body parts, but not the brain. They must have had a recent scan showing this and can't have had certain treatments in the last year. Women who can get pregnant and men must use birth control during and after treatment.

What is being tested?

The study tests if Stereotactic Ablative Body Radiation (SAbR) can delay the need for systemic therapy by targeting only a few metastatic spots in kidney cancer patients, potentially improving survival without immediately resorting to drugs affecting the whole body.

What are the potential side effects?

While specific side effects are not listed here, SAbR typically may cause fatigue, skin reactions at the treatment site, nausea or discomfort. Serious side effects might include damage to nearby organs or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney cancer has spread to no more than 3 places outside my brain.

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I am 18 years old or older.

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My kidney cancer has been confirmed by a pathology test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastasis confirmed by MRI or CT scans.

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I have had brain metastasis in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to start of systemic therapy (TTST)

Secondary study objectives

Acute Coryza

Cancer specific survival (CSS)

Health-related quality of life (HRQOL) EQ-5D

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stereotactic ablative body radiation (SABR)Experimental Treatment1 Intervention

Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic ablative body radiation (SABR)

2018

Completed Phase 2

~30

0 / 5Eligibility criteria met