SAbR For Oligometastatic Renal Cell Carcinoma

NCT02956798 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: STU 042016-046
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Oligometastatic Renal Cell Carcinoma

Keywords

Renal Cell, Stereotactic ablative body radiotherapy (SAbR), Pazopanib, Oligo-mets

Outcome Measures

Primary Outcomes (1)

• Time to start of systemic therapy (TTST)

  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.

  1 Year

Secondary Outcomes (13)

• Modified progression-free survival (mPFS) for patients who are treated with SAbR

  6 years

• Progression-free survival on systemic therapy (mPFS)

  6 years

• Overall survival (OS)

  6 years

• Cancer specific survival (CSS)

  6 years

• Local Control

  6 years

Study Arms (1)

Stereotactic ablative body radiation (SABR)

EXPERIMENTAL

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.

Radiation: Stereotactic ablative body radiation (SABR)

Interventions

Stereotactic ablative body radiation (SABR) RADIATION

SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.

Stereotactic ablative body radiation (SABR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic renal cell carcinoma with limited measurable extracranial metastases (Limited metastases, or oligometastases, defined as ≤3 sites of metastasis).
• Radiographic evidence of metastatic disease. CT should be performed within 30 days of registration.
• Pathology confirmation of Renal cell carcinoma.
• Prior surgery, or radiation is permitted.
• Age ≥ 18 years.
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and for 90 days after Radiation treatment has been completed . Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent and agrees to undergo image studies and follow up

You may not qualify if:

• Subjects with brain metastasis as assessed by contrast MRI or contrast CT scans(contrast recommended).
• Subjects with previous history of brain metastasis.
• Subjects with ≥3 unfavorable prognostic factors defined by Motzer et al. (1999), (KPS \<80% or ECOG\>1, Hgb \< LLN, LDH \>1.5x normal, corrected serum calcium \>10mg/dl and absence of prior nephrectomy), Patients with 0, 1-2, and ≥3 factors had time to death of 20 months, 10 months and 4 months.
• Subjects with life expectancy \< 6 months.
• Subjects receiving any other investigational agents
• Subjects must not be pregnant due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Study Officials

• Raquibul Hannan, MD, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 7, 2016
• Study Start: July 19, 2018
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)