Back to resultsSAbR For Oligo-Progressive Renal Cell Cancer.
Primary Purpose
Oligoprogressive Renal Cell Carcinoma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stereotactic ablative body radiation (SABR)
Sponsored by
About this trial
This is an interventional treatment trial for Oligoprogressive Renal Cell Carcinoma focused on measuring Stereotactic, Radiotherapy,
Eligibility Criteria
Inclusion Criteria:
- Pathology proven renal cell carcinoma and radiographic confirmation of metastatic renal cell carcinoma
- Patients must have drug responsive RCC as determined by treating medical or radiation oncologist after at least one set of scans.
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).
- Must be at least 18 years old
- ECOG 0-2; or KPS > 60
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.
- Ability to understand and the willingness to sign a written informed consent.
- Acceptable tolerability of ongoing therapy as decided by the treating medical oncologist
- Patient must have a desire to continue ongoing therapy
All men, as well as women of child-bearing potential 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.
A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months
Exclusion Criteria:
- Subjects with ≥3 unfavorable prognostic factors defined by IMDC (International Metastatic Renal Cell Carcinoma).
- Subjects with history of or new brain metastasis.
Sites / Locations
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic ablative body radiation (SABR)
Arm Description
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.
Outcomes
Primary Outcome Measures
Time to change of systemic therapy
SAbR for oligo-progression will be measured to delay the change of systemic therapy.
Secondary Outcome Measures
Progression-free survival (PFS)
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.
Overall survival
Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.
Number of participants with adverse events
Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. The consequences of toxicity should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Health-related quality of life (HRQOL)
HRQoL will be measured using Functional Assessment of Cancer Therapy (FACT-G)questionnaire. The FACT-G is a 28-item questionnaire that uses 5-point Likert-type response choices (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Possible scores range from 0-4, where higher scores indicate better outcome.
Health-related quality of life (HRQOL)
HRQoL is measured using EuroQoL- 5 Dimension (EQ-5D) questionnaire. EQ-5D is a patient self-administrated questionnaire. The first part consists of 5 items covering 5 dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels: 1-no problems, 2-moderate problems, and 3-extreme problems. Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 5-item index score is transformed into a utility score between. Possible scores range from 0-1, where higher score indicates better outcomes ( 0 ="Worst health state," and 1="Best health state." )
Quality of life (QOL)
HRQoL will be measured using Kidney Symptom Index (FKSI) questionnaire. FKSI is a 15 question validated symptom index for kidney cancer patients that uses 5-point Likert-type response choices (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Possible scores range from 0-4, where higher scores indicate better outcome.
Quality of life with cost involved
QOL will be measured using Cost & Convenience Questionnaire. This outcome measure will not be used and data will not be collected or analyzed because of a protocol amendment Version 4 approved on 06/26/2020.
Local control
Radiographic progression with >20% increase in the longest diameter of the treated lesions.
This outcome measure will not be used and data will not be collected or analyzed because this outcome measure was added in error at the time of the initial registration.
Full Information
NCT ID
NCT03696277
First Posted
September 28, 2018
Last Updated
July 20, 2023
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03696277
Brief Title
SAbR For Oligo-Progressive Renal Cell Cancer.
Official Title
A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
PFS on subsequent systemic therapy (PFS-SST) after progression on SAbR.
Overall survival(OS).
Toxicity, safety and tolerance.
Impact on health-related quality of life (HRQoL).
Sample Size: 20 Patients
Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligoprogressive Renal Cell Carcinoma
Keywords
Stereotactic, Radiotherapy,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic ablative body radiation (SABR)
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Stereotactic ablative body radiation (SABR)
Intervention Description
SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Primary Outcome Measure Information:
Title
Time to change of systemic therapy
Description
SAbR for oligo-progression will be measured to delay the change of systemic therapy.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
6 years
Title
Overall survival
Description
Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.
Time Frame
6 Years
Title
Number of participants with adverse events
Description
Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. The consequences of toxicity should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Time Frame
6 Years
Title
Health-related quality of life (HRQOL)
Description
HRQoL will be measured using Functional Assessment of Cancer Therapy (FACT-G)questionnaire. The FACT-G is a 28-item questionnaire that uses 5-point Likert-type response choices (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Possible scores range from 0-4, where higher scores indicate better outcome.
Time Frame
6 Years
Title
Health-related quality of life (HRQOL)
Description
HRQoL is measured using EuroQoL- 5 Dimension (EQ-5D) questionnaire. EQ-5D is a patient self-administrated questionnaire. The first part consists of 5 items covering 5 dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels: 1-no problems, 2-moderate problems, and 3-extreme problems. Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 5-item index score is transformed into a utility score between. Possible scores range from 0-1, where higher score indicates better outcomes ( 0 ="Worst health state," and 1="Best health state." )
Time Frame
6 years
Title
Quality of life (QOL)
Description
HRQoL will be measured using Kidney Symptom Index (FKSI) questionnaire. FKSI is a 15 question validated symptom index for kidney cancer patients that uses 5-point Likert-type response choices (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Possible scores range from 0-4, where higher scores indicate better outcome.
Time Frame
6 years
Title
Quality of life with cost involved
Description
QOL will be measured using Cost & Convenience Questionnaire. This outcome measure will not be used and data will not be collected or analyzed because of a protocol amendment Version 4 approved on 06/26/2020.
Time Frame
6 years
Title
Local control
Description
Radiographic progression with >20% increase in the longest diameter of the treated lesions.
This outcome measure will not be used and data will not be collected or analyzed because this outcome measure was added in error at the time of the initial registration.
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathology proven renal cell carcinoma and radiographic confirmation of metastatic renal cell carcinoma
Patients must have drug responsive RCC as determined by treating medical or radiation oncologist after at least one set of scans.
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).
Must be at least 18 years old
ECOG 0-2; or KPS > 60
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.
Ability to understand and the willingness to sign a written informed consent.
Acceptable tolerability of ongoing therapy as decided by the treating medical oncologist
Patient must have a desire to continue ongoing therapy
All men, as well as women of child-bearing potential 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.
A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months
Exclusion Criteria:
Subjects with ≥3 unfavorable prognostic factors defined by IMDC (International Metastatic Renal Cell Carcinoma).
Subjects with history of or new brain metastasis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquibul Hannan, MD, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
SAbR For Oligo-Progressive Renal Cell Cancer.
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