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SAbR For Oligometastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02956798
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

Hypothesis:

Stereotactic ablative body radiation (SAbR) prolongs progression-free survival for patients with oligometastatic kidney cancer (RCC) and delays the initiation of systemic therapy.

Primary Objectives:

• To evaluate the delay in time to start of systemic therapy (TTST) as a surrogate of progression free survival (PFS), defined as the time from the first day of SAbR to start of systemic therapy.

Secondary Objective:

  • To evaluate the modified progression-free survival (mPFS) for patients with oligometastatic renal cell carcinoma who are treated with SAbR.
  • To evaluate the overall survival (OS)
  • To evaluate the cancer specific survival (CSS)
  • To evaluate the local control rate of irradiated lesions.
  • To measure the health-related quality of life (HRQOL).

Condition or disease Intervention/treatment Phase
Oligometastatic Renal Cell Carcinoma Radiation: Stereotactic ablative body radiation (SABR) Phase 2

Detailed Description:

The study is a prospective single institution phase II single-arm open-label trial evaluating SAbR in patients with newly diagnosed oligometastatic RCC.

Problem Statements:

  • Can local therapy (SAbR) safely delay the start of systemic therapy?
  • Safely delaying the start of systemic therapy can have significant quality of life benefits for patients since systemic therapy has significant side effects.
  • Can SAbR be curative in truly oligometastatic RCC patients?

Primary Endpoint:

• Time to start of systemic therapy (TTST) defined as the time from the first day of SAbR to start of systemic therapy.

Secondary Endpoint:

  • Modified progression-free survival (mPFS) is defined as the survival interval without development of >3 sites of new metastasis, new sites of metastases that are not amenable to SAbR treatment, a total of >6 sites of metastasis that required SAbR, local failure at SAbR-treated site, or development of brain metastasis.
  • Overall Survival
  • Local control
  • Toxicity
  • HRQOL

Sample Size: 23 Patients will be enrolled.

Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stereotactic ablative body radiation (SABR)
Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR.
Radiation: Stereotactic ablative body radiation (SABR)
SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.




Primary Outcome Measures :
  1. Time to start of systemic therapy (TTST) [ Time Frame: 1 Year ]
    The delay in time to start of systemic therapy (TTST) defined as the time from the first day of SAbR to start of systemic therapy.


Secondary Outcome Measures :
  1. Modified progression-free survival (mPFS) [ Time Frame: 6 years ]
    Modified progression-free survival (mPFS) is defined as the survival interval without development of >3 sites of new metastasis, new sites of metastases that are not amenable to SAbR treatment, a total of >6 sites of metastasis that required SAbR, local failure at SAbR-treated site, or development of brain metastasis.

  2. Acute & Delayed Toxicity [ Time Frame: 6 years ]
    Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Dose adjustments should be made according to the system showing the greatest degree of toxicity. The consequences of toxicity should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 occurring prior to 270 days from the start of protocol treatment. Other treatment related toxicity attributed to the therapy will be captured, recorded and the consequences of should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE). CTCAE V4.0 along with grades 1-5 is provided in the link for reference (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06 14_QuickReference_8.5x11.pdf).

  3. Local Control [ Time Frame: 6 years ]
    Radiographic progression with >30% increase in the longest diameter of the treated lesions.

  4. Health-related quality of life (HRQOL) [ Time Frame: 6 years ]
    HRQOL will be measured using FACT-G, EQ-5D and FKSI questionnaire.



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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:

  • Metastatic renal cell carcinoma with limited measurable extracranial metastases (Limited metastases, or oligometastases, defined as ≤3 sites of metastasis).
  • Radiographic evidence of metastatic disease.
  • For previous established metastatic status, repeat biopsy is not required.
  • Prior surgery, or radiation is permitted.

Exclusion Criteria:

  • Subjects with brain metastasis as assessed by contrast MRI or contrast CT scans.
  • Subjects with previous history of brain metastasis.
  • Subjects received prior systemic therapy, except one line of immuno- or cytokine therapy (e.g. prior IL-2 or any single or combination of checkpoint inhibitors)
  • Subjects with ≥3 unfavorable prognostic factors defined by Motzer et al. (1999), (KPS <80 %, Hgb < LLN, LDH >1.5x normal, corrected serum calcium >10mg/dl and absence of prior nephrectomy), Patients with 0, 1-2, and ≥3 factors had time to death of 20 months, 10 months and 4 months.
  • Subjects with life expectancy < 6 months.
  • Subjects may not be receiving any other investigational agents.
  • Subjects must not be pregnant due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

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): NCT02956798


Contacts
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Contact: Raquibul Hannan, MD, PhD 214-645-7696 Raquibul.Hannan@UTSouthwestern.edu
Contact: Mehreen Aslam 214-648-8038 Mehreen.Aslam@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Raquibul Hannan, MD    214-645-7696    Raquibul.Hannan@UTSouthwestern.edu   
Contact: Mehreen Aslam    214-648-8038    Mehreen.Aslam@UTSouthwestern.edu   
Principal Investigator: Raquibul Hannan, MD, PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Raquibul Hannan, MD, PhD University of Texas

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02956798     History of Changes
Other Study ID Numbers: STU 042016-046
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Texas Southwestern Medical Center:
Renal Cell, Stereotactic ablative body radiotherapy (SAbR), Pazopanib, Oligo-mets

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases