Oligometastatic Renal Cell CarcinomaNCT02956798
SAbR For Oligometastatic Renal Cell Carcinoma
A study testing Stereotactic ablative body radiation (SABR) in people with Oligometastatic Renal Cell Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic 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
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2018to 24 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
- Prior surgery, or radiation is permitted.
- Age ≥ 18 years.
- 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.
Show all 10Show fewer
- A female of child-bearing potential is any woman (regardless of sexual orientation, 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).
- Ability to understand and the willingness to sign a written informed consent and agrees to undergo image studies and follow up
Who cannot join
- 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.
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: Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma
Hypothesis:
Stereotactic ablative body radiation (SAbR) prolongs progression-free survival for patients with oligometastatic kidney cancer (RCC) and delays the initiation of systemic therapy.
Read more
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).
Read the 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.
- Conditions
- Oligometastatic Renal Cell Carcinoma
- Being tested
- Stereotactic ablative body radiation (SABR)
- Keywords
- Renal Cell, Stereotactic ablative body radiotherapy (SAbR), Pazopanib, Oligo-mets
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 | 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. Receives: Radiation: Stereotactic ablative body radiation (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Delay in Time to Start of Systemic Therapy (TTST)
The percentage of participants with more than 1 year time to systemic therapy (TTST) will be reported for this outcome. Initiation of systemic therapy >1 year (delay in time) is a surrogate of progression free survival (PFS) and is defined as the time from the first day of SAbR to start of systemic therapy.
Measured: 1 Year
Secondary outcomes (18)
Modified Progression-free Survival (mPFS) for Patients Who Are Treated With SAbR
Modified progression-free survival (mPFS) for patients with oligometastatic renal cell carcinoma who are treated with SAbR. 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.
Measured: 5.7 years
Progression-free Survival on Systemic Therapy (PFS-ST)
To evaluate progression on next line of systemic therapy as defined by RECIST 1.1 starting from mPFS (modified progression free survival). Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) Committee [Eur J Cancer. 2009;45(2):228-247]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria.
Measured: 5.7 years
Overall Survival (OS)
Overall survival (OS), which is defined as the time between date of registration and the date of death due to any cause.
Measured: 5.7 years
Cancer Specific Survival (CSS)
Cancer specific survival is defined as the time between date of registration and the date of death due to renal cell carcinoma.
Measured: 5.7 years
Local Control
Radiographic progression with >30% increase in the longest diameter of the treated lesions.
Measured: 5.7 years
Median Response Duration
Median response duration is defined as the time between the date a response (CR or PR) was first seen until date of progression. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) Committee [Eur J Cancer. 2009;45(2):228-247]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria.
Measured: 1.8 years
Time to Development of New Lesions
Interval time to development of new lesions that can be treated with additional local therapy- title would be this or a shortened version of it. Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.
Measured: 5.7 years
Time to Disease Progression That Cannot be Treated
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 to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.
Measured: 5.7 years
Toxicity Measurement
Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Events have been counted if they are considered related to the investigational intervention included "possible," "probable," and "definite." To ensure transparency, all AEs with "unlikely" or greater attribution are included.
Measured: 5.7years
Change in Health-related Quality of Life (HRQOL) FACT-G
HRQOL will be measured using FACT-G questionnaire responses from baseline to certain time points (3, 9, 15,21,27,33 months) until the completion of follow ups. FACT-G is a measure that sums the functional wellbeing (FWB), physical wellbeing (PWB), the social/family well-being (S/FWB), and emotional wellbeing (EMB).FACT-G total score range (0-108); Higher values indicate a better HRQOL.
Measured: [Baseline-3mon (months)];(Baseline-9mon.);(Baseline-15mon.); (Baseline-21mon.);(Baseline-27mon.);(Baseline-33mon.)
Change in Health-related Quality of Life (HRQOL) EQ-VAS
HRQOL will be measured using EQ-VAS (EuroQol- Visual analog scale) questionnaire at baseline and at specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. The EQ-VAS is a global measure of patient perception of their health ranging from 0-100, with 0 being the worst health they can imagine, and 100 being the best health they can imagine.
Measured: [Baseline-3mon (months)];(Baseline-9mon.);(Baseline-15mon.); (Baseline-21mon.);(Baseline-27mon.);(Baseline-33mon.)
Change in Health-related Quality of Life (HRQOL) EQ-5D at 3 Months
HRQOL will be measured using EQ-5D (EuroQol- 5 Dimension) questionnaire at baseline and at certain specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including the domains - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline, 3months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 9 Months
HRQOL will be measured using EQ-5D (EuroQol- 5 Dimension) questionnaire at baseline and at certain specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including the domains - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline, 9 months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 15 Months
HRQOL will be measured using EQ-5D (EuroQol- 5 Dimension) questionnaire at baseline and at certain specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including the domains - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline, 15 months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 21 Months
HRQOL will be measured using EQ-5D (EuroQol- 5 Dimension) questionnaire at baseline and at certain specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including the domains - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline, 21 months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 27 Months
HRQOL will be measured using EQ-5D (EuroQol- 5 Dimension) questionnaire at baseline and at certain specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including the domains - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline, 27 months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 33 Months
HRQOL will be measured using EQ-5D (EuroQol- 5 Dimension) questionnaire at baseline and at certain specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including the domains - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline, 33 months
Change in Health-related Quality of Life (HRQOL) FKSI
HRQOL will be measured using FKSI questionnaire at baseline and at certain specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. FKSI adds to the FACT-G (27 items) by including 15 items specific to kidney cancer patients. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.
Measured: [Baseline-3mon (months)];(Baseline-9mon.);(Baseline-15mon.); (Baseline-21mon.);(Baseline-27mon.);(Baseline-33mon.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start19 Jul 2018
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oligometastatic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT02956798
- Sponsor's protocol ID
- STU 042016-046
- Status last verified
- Aug 2026
- First submitted
- 26 Oct 2016
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02956798
- Acronym / sponsor ID
- STU 042016-046
- Conditions
- Oligometastatic Renal Cell Carcinoma
- Keywords
- Renal Cell, Stereotactic ablative body radiotherapy (SAbR), Pazopanib, Oligo-mets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Prior surgery, or radiation is permitted.
- Age ≥ 18 years.
Key exclusion criteria (7 listed)
- 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.
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
Percentage of Participants With Delay in Time to Start of Systemic Therapy (TTST)
Time frame: 1 Year
The percentage of participants with more than 1 year time to systemic therapy (TTST) will be reported for this outcome. Initiation of systemic therapy >1 year (delay in time) is a surrogate of progression free survival (PFS) and is defined as the time from the first day of SAbR to start of systemic therapy.
18 secondary outcomes
Modified Progression-free Survival (mPFS) for Patients Who Are Treated With SAbR
Time frame: 5.7 years
Progression-free Survival on Systemic Therapy (PFS-ST)
Time frame: 5.7 years
Overall Survival (OS)
Time frame: 5.7 years
Cancer Specific Survival (CSS)
Time frame: 5.7 years
Local Control
Time frame: 5.7 years
Median Response Duration
Time frame: 1.8 years
Time to Development of New Lesions
Time frame: 5.7 years
Time to Disease Progression That Cannot be Treated
Time frame: 5.7 years
Toxicity Measurement
Time frame: 5.7years
Change in Health-related Quality of Life (HRQOL) FACT-G
Time frame: [Baseline-3mon (months)];(Baseline-9mon.);(Baseline-15mon.); (Baseline-21mon.);(Baseline-27mon.);(Baseline-33mon.)
Change in Health-related Quality of Life (HRQOL) EQ-VAS
Time frame: [Baseline-3mon (months)];(Baseline-9mon.);(Baseline-15mon.); (Baseline-21mon.);(Baseline-27mon.);(Baseline-33mon.)
Change in Health-related Quality of Life (HRQOL) EQ-5D at 3 Months
Time frame: Baseline, 3months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 9 Months
Time frame: Baseline, 9 months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 15 Months
Time frame: Baseline, 15 months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 21 Months
Time frame: Baseline, 21 months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 27 Months
Time frame: Baseline, 27 months
Change in Health-related Quality of Life (HRQOL) EQ-5D at 33 Months
Time frame: Baseline, 33 months
Change in Health-related Quality of Life (HRQOL) FKSI
Time frame: [Baseline-3mon (months)];(Baseline-9mon.);(Baseline-15mon.); (Baseline-21mon.);(Baseline-27mon.);(Baseline-33mon.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 study testing Stereotactic ablative body radiation (SABR) in people with Oligometastatic 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 10 inclusion and 7 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 31 Aug 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Delay in Time to Start of Systemic Therapy (TTST) (time frame: 1 Year). 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 31 Aug 2026.