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SAbR For Oligo-Progressive Renal Cell Cancer.

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ClinicalTrials.gov Identifier: NCT03696277
Recruitment Status : Active, not recruiting
First Posted : October 4, 2018
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE September 28, 2018
First Posted Date  ICMJE October 4, 2018
Last Update Posted Date November 10, 2020
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
Time to change of systemic therapy [ Time Frame: 2 Years ]
SAbR for oligo-progression will be measured to delay the change of systemic therapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
  • Progression-free survival (PFS) [ Time Frame: 6 years ]
    Progression-Free Survival on systemic therapy started (PFS-ST) after progression on SAbR with existing or new progression at >3 or >30% of all lesions.
  • 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. The consequences of toxicity should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
  • Local Control [ Time Frame: 6 Years ]
    Radiographic progression with >20% 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.
  • Health-related quality of life (HRQOL) [ Time Frame: 6 years ]
    HRQOL will be measured using EQ-5D-5L.
  • Quality of life (QOL) [ Time Frame: 6 years ]
    HRQOL will be measured using FKSI.
  • Quality of life with cost involved [ Time Frame: 6 years ]
    QOL will be measured using Cost & Convenience Questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SAbR For Oligo-Progressive Renal Cell Cancer.
Official Title  ICMJE A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).
Brief Summary

Metastatic kidney cancer patients on systemic therapy often develop resistance to limited sites that leads to changing of the systemic therapy. Local therapy to the sites of progression may allow patients to continue on the same systemic therapy that is otherwise effective and being tolerated well.

Hypothesis:

Stereotactic ablative radiation (SAbR) can delay the change of systemic therapy with oligoprogressive renal cell cancer (RCC) and improve progression free survival (PFS).

Primary Objectives:

• To evaluate the benefit of SAbR for oligo-progressive mRCC (Metastatic Renal Cell Cancer).

Secondary Objectives:

• To measure the toxicity, safety and tolerance of concurrent systemic therapy and SAbR for mRCC patients and its impact on quality of life.

Detailed Description

The study is a prospective phase II, single arm, open label trial evaluating Stereotactic Ablative Radiation Therapy (SAbR) for patients with oligo-progressive RCC (Renal Cell Cancer).

Problem Statements:

  • Can local therapy (SAbR) for oligoprogression delay the change of systemic therapy if progression is minimal to the progressive sites?
  • Safely delaying the change of systemic therapy can have significant quality of life benefits for patients with oligo-progressive RCC.
  • Can SAbR potentially improve progression free survival in oligoprogressive RCC patients?

Primary Endpoint:

• Time to change of systemic therapy.

Secondary Endpoint:

  • To measure the toxicity, safety and tolerance.
  • To evaluate the progression free survival (PFS) on subsequent systemic therapy after progression on SAbR.
  • To measure the impact on health-related quality of life (HRQOL).
  • To evaluate local control of SAbR for RCC

Sample Size: 20 Patients

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 Oligoprogressive 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)
SAbR will be used to treat all sites of measurable metastases. New sites of metastasis will be treated 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2024
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pathology proven renal cell carcinoma and radiographic confirmation of metastatic renal cell carcinoma
  2. Patients must have drug responsive RCC as determined by treating medical oncologist after at least one set of scans.
  3. Must be on systemic therapy with radiographic scans to verify olio-progression of ≤3 sites and ≤ 30% of all sites.

    • Any FDA approved systemic therapy for RCC is allowed. Currently these include small molecule tyrosine kinase inhibitors (TKIs) targeting the vascular endothelial growth factor (VEGF) pathway (sunitinib, pazopanib, cabozantinib, axitinib, sorafenib), monoclonal antibody targeting the same pathway (bevacizumab), the mammalian target of rapamycin pathway (temsirolimus, everolimus), Immune checkpoint inhibitors (Nivolumab and Nivolumab concurrent with Ipilimumab, Lenvatinib in combination with everolimus and nivolumab).

  4. Must be at least 18 years old
  5. ECOG 0-2; or KPS > 60
  6. Currently receiving 1st - 4th line of systemic therapy

    • Any of the above listed systemic therapy is allowed as long as they are being used in the 1st-4th line setting.

  7. Ability to understand and the willingness to sign a written informed consent.
  8. Acceptable tolerability of ongoing therapy as decided by the treating medical oncologist
  9. Patient must have a desire to continue ongoing therapy
  10. 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, for the duration of study participation, and for 90 days following completion of therapy. 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 with ≥3 unfavorable prognostic factors defined by IMDC (International Metastatic Renal Cell Carcinoma).
  • Subjects with history of or new brain metastasis.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03696277
Other Study ID Numbers  ICMJE STU 052018-001
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: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 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 July 2020

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