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Trial record 2 of 34 for:    hannan

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 19, 2020
Sponsor:
Information provided by (Responsible Party):
Raquibul Hannan, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Renal Cancers Radiation: Stereotactic Ablative Radiation Therapy Phase 2

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.

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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 2021
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

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 Name: SABR




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 2 years ]
    To describe the adverse events associated with the administration of SABR to renal tumors.

  2. growth rate of renal tumors [ Time Frame: 2 years ]
    To measure the growth rate of renal tumors after SABR treatment.

  3. Renal function [ Time Frame: 2 years ]
    To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment

  4. Tumor Viability [ Time Frame: one year ]
    To measure tumor viability pathologically one year after SABR treatment with biopsy.

  5. 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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75239
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Raquibul Hannan, MD, PhD UTSW
  Study Documents (Full-Text)

Documents provided by Raquibul Hannan, University of Texas Southwestern Medical Center:
Study Protocol  [PDF] May 19, 2020

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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 19, 2020
Last Verified: October 2020
Keywords provided by Raquibul Hannan, University of Texas Southwestern Medical Center:
renal cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type