A Phase 2 interventional study of Stereotactic ablative body radiation (SABR) in Oligoprogressive Renal Cell Carcinoma, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment
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:
Secondary Objectives:
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:
Primary Endpoint:
Secondary Endpoint:
Sample Size: 20 Patients
Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 21 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Must be on systemic therapy with radiographic scans to verify olio-progression of ≤3 sites and ≤ 30% of all sites.
Currently receiving 1st - 4th line of systemic 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:
Exclusion Criteria:
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.
Radiation: Stereotactic ablative body radiation (SABR)
SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Time to change of systemic therapy
SAbR for oligo-progression will be measured to delay the change of systemic therapy.
Time frame: 2 Years
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.
Time frame: 6 years
Overall survival
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
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.
Time frame: 6 Years
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.
Time frame: 6 Years
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." )
Time frame: 6 years
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.
Time frame: 6 years
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.
Time frame: 6 years
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.
Time frame: 6 years
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center