Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer

NCT02141919 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: STU 122013-030
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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 Therapy RADIATION

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Renal mass ≤ 5cm
• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75239, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Raquibul Hannan, MD, PhD

  UTSW

  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: May 12, 2014
• First Posted: May 20, 2014
• Study Start: June 1, 2013
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)