SAbR For Oligometastatic Renal Cell Carcinoma
NCT02956798 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2025-07-28
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
Interventions
- RADIATION
-
Stereotactic ablative body radiation (SABR)
SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Sponsors & Collaborators
-
University of Texas Southwestern Medical Center
lead OTHER
Principal Investigators
-
Raquibul Hannan, MD, PhD · University of Texas
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-19
- Primary Completion
- 2025-12-30
- Completion
- 2025-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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