SABR for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByRaquibul Hannan, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Hypothesis: Stereotactic ablative body radiation (SAbR) prolongs progression-free survival for patients with oligometastatic kidney cancer (RCC) and delays the initiation of systemic therapy. Primary Objectives: • To evaluate the delay in time to start of systemic therapy (TTST) as a surrogate of progression free survival (PFS), defined as the time from the first day of SAbR to start of systemic therapy. Secondary Objective: * To evaluate the modified progression-free survival (mPFS) for patients with oligometastatic renal cell carcinoma who are treated with SAbR. * To evaluate the overall survival (OS) * To evaluate the cancer specific survival (CSS) * To evaluate the local control rate of irradiated lesions. * To measure the health-related quality of life (HRQOL).

Eligibility Criteria

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.

Inclusion Criteria

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

I am 18 years old or older.

My kidney cancer has been confirmed by a pathology test.

Exclusion Criteria

I have brain metastasis confirmed by MRI or CT scans.

I have had brain metastasis in the past.

Participant Groups

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.

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.