NCT02141919

Active Not RecruitingPhase 2

Stereotactic Ablative Body Radiation Therapy for Patients Wi...

University of Texas Southwestern Medical Center Source

University of Texas Southwestern Medical Center

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

STU 122013-030

Study Type

interventional

Actual enrollment (reported)

16

Locations

1 country

Sites

1

Timeline

Study Start

June 2013

Actual (reported)

Primary Completion

May 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Actual enrollment (reported): 16 participants
Study completion date: June 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2013
Actual (reported)
First Submitted
May 12, 2014
Actual (reported)
First Posted
May 20, 2014
Actual (reported)
Primary Completion
May 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: December 26, 2025
Status Verified: December 2025
Last Update Submitted: December 23, 2025

Conditions

Renal Cancers

Keywords

renal cancer

Outcome Measures

Primary Outcomes (1)

Eliminate its growth and tumor viability.
To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.
2 years

Secondary Outcomes (5)

Adverse events
2 years
growth rate of renal tumors
2 years
Renal function
2 years
Tumor Viability
one year
progression of disease
2 years

Study Arms (1)

Stereotactic Ablative Radiation Therapy

EXPERIMENTAL

Stereotactic Ablative Radiation Therapy (SABR)

Radiation: Stereotactic Ablative Radiation Therapy

Interventions

Stereotactic Ablative Radiation TherapyRadiation

Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy

Also known as: SABR

Stereotactic Ablative Radiation Therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years.
Renal mass ≤ 5cm

Sponsors & Collaborators

University of Texas Southwestern Medical Center
Otherlead

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75239, United States

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

Raquibul Hannan, MD, PhD
UTSW
PRINCIPAL INVESTIGATOR

Enrollment

16 participants (actual enrollment reported by the registry).

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

May 12, 2014

First Posted

May 20, 2014

Study Start

June 2013

Actual (reported)

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Phase 2Completed

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Phase 2Terminated

NCT01217931

Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial

Phase 2Active Not Recruiting

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Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery

Phase 2Completed

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High-dose Bevacizumab in Advanced Renal Carcinoma Patients

Phase 2Completed

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The treating renal mass must be ≤ 5cm. Other renal masses (cysts etc.) of any size will not make the subject ineligible

Biopsy proven Renal neoplasm

All histology of renal cancers are included including oncocytoma

Growth of renal mass \>2mm in radiographic scans must be demonstrated within a one year period.

Ability to understand and the willingness to sign a written informed consent.

Subject is able to undergo either an MRI or administration of contrast agent for CT

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study. 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).

You may not qualify if:

Subject has received any treatment for the treating renal mass; such as RFA or cyroablation.
If other renal masses received RFA or cryoablation or surgery, then these patients are eligible.
Subjects received previous abdominal radiation
Evidence of Metastatic Disease, unless disease-free for ≥ 3 years prior to registration, (non-melanomatous skin cancer and in-situ cancers are okay).
Female subjects who are pregnant or planning to become pregnant during the course of SABR.

Contact the study team to confirm eligibility.

Primary Completion

May 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

December 26, 2025

Record last verified: 2025-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02141919
Data provider: ClinicalTrials.gov
Source updated: 2025-12-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:28 UTC

Documents

Study Protocol
Protocol2020-05-19

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Stereotactic Ablative Radiation Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations