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Trial record 1 of 17 for:    A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients with Primary Renal Cell Carcinoma (RCC)
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Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02141919
Recruitment Status : Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Raquibul Hannan, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 20, 2014
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE June 2013
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
Eliminate its growth and viable tumor. [ Time Frame: 2 years ]
To evaluate if SABR to SRMs is able to eliminate its growth and viable tumor.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • Adverse events [ Time Frame: 2 years ]
    To describe the adverse events associated with the administration of SABR to SRMs
  • growth rate of SRMs [ Time Frame: 2 years ]
    To measure the growth rate of SRMs 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 for patients that consents to the optional biopsy.
  • Tumor measurement [ Time Frame: 2 years ]
    To assess radiographic changes of the SRM after SABR treatment, including tumor viability, %enhancement, necrosis, T2 signal, tumor cellularity with diffusion-weighted imaging
  • progression of disease [ Time Frame: 2 years ]
    To assess local, regional and systemic progression of disease after SABR to SRM
  • time to progression [ Time Frame: 2 years ]
    To assess time to progression (TTP) of disease from the first SABR treatment.
  • progression free survival [ Time Frame: 2 years ]
    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.
  • overall survival [ Time Frame: 2 years ]
    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
  • Disease response [ Time Frame: 2 years ]
    To assess tumor growth, local failure and indeterminate disease response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 15, 2014)
  • cytokine changes [ Time Frame: 2 years ]
    To evaluate the cytokine changes brought on by SABR to SRM and to evaluate generation of any immune response specific to tumor cells.
  • radiographic spatial-temporal tumor features [ Time Frame: 2 years ]
    To evaluate whether radiographic spatial-temporal tumor features extracted from CT and MRI can be used to predict treatment response of tumor to SABR.
 
Descriptive Information
Brief Title  ICMJE Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
Official Title  ICMJE A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cancers
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Stereotactic Ablative Radiation Therapy
Stereotactic Ablative Radiation Therapy (SABR)
Intervention: Radiation: Stereotactic Ablative Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 15, 2014)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Age ≥ 18 years.
  • Renal mass ≤ 5cm
  • 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 3.1.7 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.

Exclusion Criteria:

  • Subjects may not have received any treatment for the renal mass such as RFA or cryoablation.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02141919
Other Study ID Numbers  ICMJE STU 122013-030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raquibul Hannan, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raquibul Hannan, MD, PhD UTSW
PRS Account University of Texas Southwestern Medical Center
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP