Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer

A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Renal Cancers
• Intervention / Treatment: Radiation: Stereotactic Ablative Radiation Therapy

Detailed Description

Current treatment options for primary renal cancer include surgery or ablative techniques-all are invasive or minimally invasive options. The completely noninvasive treatment option of stereotactic radiation therapy (SABR), which has become standard of care in many cancer sites, has not been explored for primary renal cancer. With multiple technological advances, it is now feasible to safely treat a moving intra-abdominal tumor such as that in a kidney. This proposed clinical trial evaluates the efficacy of SABR in treating patients with early renal cancers. Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer. Patients will then undergo treatment with SABR of 3-5 fractions completing within three weeks. Treatment response will be evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75239
      • University of Texas Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic Ablative Radiation Therapy; Stereotactic Ablative Radiation Therapy (SABR)	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 Names: SABR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	To describe the adverse events associated with the administration of SABR to renal tumors.	2 years
growth rate of renal tumors	To measure the growth rate of renal tumors after SABR treatment.	2 years
Renal function	To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment	2 years
Tumor Viability	To measure tumor viability pathologically one year after SABR treatment with biopsy.	one year
progression of disease	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).	2 years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Raquibul Hannan, MD, PhD, UTSW

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 15, 2014
• First Posted (Estimated): May 20, 2014

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: renal cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: STU 122013-030