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Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer

Primary Purpose

Renal Cancers

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Ablative Radiation Therapy
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cancers focused on measuring renal cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas Southwestern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Ablative Radiation Therapy

Arm Description

Stereotactic Ablative Radiation Therapy (SABR)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2014
Last Updated
August 21, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02141919
Brief Title
Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
Official Title
A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2013 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancers
Keywords
renal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Ablative Radiation Therapy
Arm Type
Experimental
Arm Description
Stereotactic Ablative Radiation Therapy (SABR)
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Ablative Radiation Therapy
Other Intervention Name(s)
SABR
Intervention Description
Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy
Primary Outcome Measure Information:
Title
Eliminate its growth and tumor viability.
Description
To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Adverse events
Description
To describe the adverse events associated with the administration of SABR to renal tumors.
Time Frame
2 years
Title
growth rate of renal tumors
Description
To measure the growth rate of renal tumors after SABR treatment.
Time Frame
2 years
Title
Renal function
Description
To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment
Time Frame
2 years
Title
Tumor Viability
Description
To measure tumor viability pathologically one year after SABR treatment with biopsy.
Time Frame
one year
Title
progression of disease
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquibul Hannan, MD, PhD
Organizational Affiliation
UTSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75239
Country
United States

12. IPD Sharing Statement

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Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer

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