Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
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ClinicalTrials.gov Identifier: NCT02141919 |
Recruitment Status :
Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : October 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Renal Cancers | Radiation: Stereotactic Ablative Radiation Therapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC) |
Actual Study Start Date : | June 2013 |
Estimated Primary Completion Date : | November 2024 |
Estimated Study Completion Date : | December 2025 |

Arm | Intervention/treatment |
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Experimental: Stereotactic Ablative Radiation Therapy
Stereotactic Ablative Radiation Therapy (SABR)
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Radiation: Stereotactic Ablative Radiation Therapy
Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy
Other Name: SABR |
- Eliminate its growth and tumor viability. [ Time Frame: 2 years ]To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.
- Adverse events [ Time Frame: 2 years ]To describe the adverse events associated with the administration of SABR to renal tumors.
- growth rate of renal tumors [ Time Frame: 2 years ]To measure the growth rate of renal tumors after SABR treatment.
- Renal function [ Time Frame: 2 years ]To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment
- Tumor Viability [ Time Frame: one year ]To measure tumor viability pathologically one year after SABR treatment with biopsy.
- progression of disease [ Time Frame: 2 years ]
To assess radiographic changes to the renal tumor after SABR treatment including tumor viability, enhancement necrosis,T2 tumor cellularity with diffusion-weighted imaging. To assess local, regional and systemic progression of disease after SABR to SRM .To assess time to progression (TTP) of disease from the first SABR treatment.
To assess progression free survival (PFS). PFS is defined as the length of time from start of treatment to the time of loco-regional disease progression or death from any cause.
To assess overall survival (OS). OS is defined as the duration of time from start of treatment to the time of death from any cause.
To assess tumor growth, local failure and indeterminate disease response (IDR).

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Age ≥ 18 years.
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Renal mass ≤ 5cm
- The treating renal mass must be ≤ 5cm. Other renal masses (cysts etc.) of any size will not make the subject ineligible
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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.
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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).
Exclusion Criteria:
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141919
United States, Texas | |
University of Texas Southwestern | |
Dallas, Texas, United States, 75239 |
Principal Investigator: | Raquibul Hannan, MD, PhD | UTSW |
Documents provided by Raquibul Hannan, University of Texas Southwestern Medical Center:
Responsible Party: | Raquibul Hannan, Associate Professor of Medicine, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT02141919 |
Other Study ID Numbers: |
STU 122013-030 |
First Posted: | May 20, 2014 Key Record Dates |
Last Update Posted: | October 22, 2021 |
Last Verified: | October 2021 |
renal cancer |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Carcinoma Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Neoplasms Urologic Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |