Oligoprogressive Renal Cell CarcinomaPhase 2NCT03696277
SAbR For Oligo-Progressive Renal Cell Cancer.
A Phase 2 study testing Stereotactic ablative body radiation (SABR) in people with Oligoprogressive Renal Cell Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligoprogressive Renal Cell Carcinoma
- What is being tested?
- Stereotactic ablative body radiation (SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 23 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Subjects with ≥3 unfavorable prognostic factors defined by IMDC (International Metastatic Renal Cell Carcinoma).
- Subjects with history of or new brain metastasis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).
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:
Read more
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.
Read the 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.
- Conditions
- Oligoprogressive Renal Cell Carcinoma
- Being tested
- Stereotactic ablative body radiation (SABR)
- Keywords
- Stereotactic, Radiotherapy,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic ablative body radiation (SABR)Radiation
SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic ablative body radiation (SABR) | Experimental | 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. Receives: Radiation: Stereotactic ablative body radiation (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to change of systemic therapy
SAbR for oligo-progression will be measured to delay the change of systemic therapy.
Measured: 2 Years
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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." )
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Oct 2018
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligoprogressive Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquibul Hannan, University of Texas Southwestern Medical Center
- Investigators
- Raquibul Hannan, MD, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696277
- Sponsor's protocol ID
- STU 052018-001
- Status last verified
- Jul 2024
- First submitted
- 28 Sep 2018
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).
- ClinicalTrials.gov ID
- NCT03696277
- Acronym / sponsor ID
- STU 052018-001
- Conditions
- Oligoprogressive Renal Cell Carcinoma
- Keywords
- Stereotactic, Radiotherapy,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic ablative body radiation (SABR) | Experimental | Radiation: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Must be at least 18 years old
- ECOG 0-2; or KPS > 60
Key exclusion criteria (2 listed)
- Subjects with ≥3 unfavorable prognostic factors defined by IMDC (International Metastatic Renal Cell Carcinoma).
- Subjects with history of or new brain metastasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic ablative body radiation (SABR)SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions. | Radiation | Stereotactic ablative body radiation (SABR) |
Primary outcome
Time to change of systemic therapy
Time frame: 2 Years
SAbR for oligo-progression will be measured to delay the change of systemic therapy.
8 secondary outcomes
Progression-free survival (PFS)
Time frame: 6 years
Overall survival
Time frame: 6 Years
Number of participants with adverse events
Time frame: 6 Years
Health-related quality of life (HRQOL)
Time frame: 6 Years
Health-related quality of life (HRQOL)
Time frame: 6 years
Quality of life (QOL)
Time frame: 6 years
Quality of life with cost involved
Time frame: 6 years
Local control
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquibul Hannan, MD, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic ablative body radiation (SABR) in people with Oligoprogressive Renal Cell Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to change of systemic therapy (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.