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SAbR For Oligometastatic Renal Cell Carcinoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956798
Recruitment Status : Recruiting
First Posted : November 6, 2016
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Raquibul Hannan, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE October 26, 2016
First Posted Date  ICMJE November 6, 2016
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE July 19, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
Time to start of systemic therapy (TTST) [ Time Frame: 1 Year ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
progression-free survival [ Time Frame: 5 years ]
Progression-free survival (PFS) is defined as the survival interval with or without local therapy until there is objective progression as defined by RECIST 1.1
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • 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, with the definition of new metastasis and local failure (progression) as defined by RECIST. "Metastasis" in this entire protocol refers to extra-cranial metastasis unless otherwise specified.
  • 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 5.0. 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 5.0 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 V5.0 along with grades 1-5.
  • Local Control [ Time Frame: 6 years ]
    Radiographic progression with >30% increase in the longest diameter of the treated lesions.
  • Health-related quality of life (HRQOL) [ Time Frame: 6 years ]
    HRQOL will be measured using FACT-G, EQ-5D and FKSI questionnaire.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • overall survival [ Time Frame: 10 years ]
    It is defined as the time between date of registration and the date of death due to any cause
  • cancer specific survival [ Time Frame: 10 years ]
    It is defined as the time between date of registration and the date of death due to renal cell carcinoma.
  • local control rate [ Time Frame: 5 years ]
    the local control rate of irradiated lesions
  • median response duration [ Time Frame: 5 years ]
    It is defined as the time between the date a response (CR or PR) was first seen until date of progression
  • rate of toxicity [ Time Frame: 5 years ]
    percentage of adverse events will be calculated for all subjects having received at least one dose of study drug. The study will use the CTCAE version 4.0 for reporting of non-. hematologic adverse events and modified criteria for hematologic adverse events.
  • time to disease progression [ Time Frame: 10 years ]
    To measure the time interval from registration to time to disease progression that cannot be treated with further local therapy and need to initiate or switch systemic therapy.
  • time developing new lesions [ Time Frame: 5 years ]
    To measure the time interval from registration to time developing new lesions that can be treated with local therapy
  • cost-effectiveness analysis [ Time Frame: 5 years ]
    To evaluate the cost-effectiveness analysis of this treatment regimen to the other current first and second line treatments for renal cell cancer metastases
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SAbR For Oligometastatic Renal Cell Carcinoma
Official Title  ICMJE Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma
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).
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.

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 Oligometastatic Renal Cell Carcinoma
Intervention  ICMJE Radiation: Stereotactic ablative body radiation (SABR)
SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Study Arms  ICMJE 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.
Intervention: Radiation: Stereotactic ablative body radiation (SABR)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
48
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
36
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. CT should be performed within 30 days of registration.
  • Pathology confirmation of Renal cell carcinoma.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and for 90 days after Radiation treatment has been completed . Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Prior surgery, or radiation is permitted.
  • Ability to understand and the willingness to sign a written informed consent and agrees to undergo image studies and follow up
  • Age ≥ 18 years.

Exclusion Criteria:

  • Subjects with brain metastasis as assessed by contrast MRI or contrast CT scans(contrast recommended).
  • Subjects with previous history of brain metastasis.
  • Subjects that received prior systemic therapy for kidney cancer in the past 1 year, except one line of immuno- or cytokine therapy (e.g. prior IL-2); systemic therapy for other cancers does not apply to this exclusion criteria
  • Subjects with ≥3 unfavorable prognostic factors defined by Motzer et al. (1999), (KPS <80% or ECOG>1, 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Hardee, MS 2146458525 sarah.hardee@utsouthwestern.edu
Contact: Kajal Desai 2146458525 kajal.desai@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956798
Other Study ID Numbers  ICMJE STU 042016-046
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 University of Texas
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