Carcinoma, Renal CellPhase 1/2NCT02782715
Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma
A Phase 1/2 study testing Stereotactic Body Radiation Therapy (SBRT) and Microwave Ablation (MWA) in people with Carcinoma, Renal Cell, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The specific aims of this study are: 1. To determine the safety and feasibility of treating patients with a combination of MRI guided stereotactic body radiation therapy and microwave ablation. 2. To assess short and long-term toxicity rates of patients treated with a combined modality approach. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) and Microwave Ablation (MWA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 10 Jan 2023
- Phase
- Phase 1/2
- 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
- Patients with imaging findings consistent with renal cell carcinoma
- Deemed medically inoperable per urology evaluation
- Tumor size >4cm in largest dimension
- ECOG performance status of <2
- Signed informed consent document(s)
- Patients with metastatic disease will not be excluded
Who cannot join
- Patients who fail MRI screening
- Pregnant or nursing women
- History of prior radiation therapy to the upper abdomen
- History of invasive cancer in the last 3 years (except for appropriately treated low-rist prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer)
- Treatment with a non-approved or investigational drug within 28 days of study treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
About this study
Official title: Real-time MRI-Guided Stereotactic Body Radiation Therapy and Microwave Ablation for Non-Operable Renal Cell Carcinoma
The specific aims of this study are:
- To determine the safety and feasibility of treating patients with a combination of MRI guided stereotactic body radiation therapy and microwave ablation.
- To assess short and long-term toxicity rates of patients treated with a combined modality approach.
- To assess local control, survival, and pathologic response to treatment
Read the detailed description
Renal cell carcinoma is traditionally managed via a surgical approach. Increasingly, local therapy with radiofrequency and microwave ablation is being utilized as an alternative for patients who may not tolerate a nephrectomy or who refuse one. Although local control rates for small lesions are excellent, they drop off precipitously for lesions over 4 cm. Furthermore, lesions in critical areas such as the renal hilum may be difficult to treat with this method. Stereotactic body radiation therapy (SBRT) has had a long record of treating patients with inoperable tumors in locations such as the lung and central nervous system, and there is increasing evidence that it may be useful for patients with renal cell carcinoma. The recent emergence of MRI-guided radiation therapy allows for direct visualization of tumors during treatment, and may potentially allow clinicians to treat tumors more precisely. This phase I study will treat renal cell carcinoma patients using a combination of MRI-guided stereotactic body radiation therapy and microwave ablation.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Microwave Ablation (MWA)
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Patients will be treated on study with a course of SBRT treatment by a radiation oncologist. Three SBRT dose levels targeting the primary tumor will be evaluated; level I: 6 Gy x 5 fractions (a common palliative dose), level II: 8 Gy x 5 fractions, and level III: 10 Gy x 5 fractions (a common definitive dose).
Microwave Ablation (MWA)Procedure or surgery
Performed under sedation using ultrasound and computed tomography (CT) guidance for percutaneous antenna placement and confirmation. Depending on size and location of tumor, one to three antennas (Certus 140; NeuWave Medical) will be used. The system is an FDA-approved, high-powered third-generation MW device that uses CO2 gas cooling to prevent shaft heating. The gas cooling allows the probes to be stuck into tissue by creating a small ice ball at the tip using the Joule-Thomson method, similar to the tissue cooling mechanism of cryoablation systems. Probes are 17-gauge, and various ablation zone configurations are available depending on the probe selected. An ablation protocol using the 65W power setting for 5 minutes will be used for most patients. Ultrasound will be used for real-time monitoring of the extent of ablation to achieve a 5mm margin beyond tumor, and immediate post-procedure imaging performed using contrast-enhanced CT (CECT) for patients with adequate renal functions.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy & Microwave Ablation | Experimental | 3+3 dose-escalation wherein three dose levels of stereotactic body radiation therapy (SBRT) would be evaluated:
1. Dose level I: 6 Gy x 5 fractions
2. Dose level II: 8 Gy x 5 fractions
3. Dose level III: 10 Gy x 5 fractions
Radiation treatments will be delivered two to three times a week, with five fractions completed over two weeks.
Four to six weeks after radiation treatment, patients will undergo repeat CT or MRI imaging to assess tumor response and suitability for microwave ablations.
Eight weeks after the conclusion of SBRT, patients will undergo microwave ablation (approximately 12 weeks after registration). Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Microwave Ablation (MWA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma
Dose-limiting toxicity (DLT) will be defined as grade 4 or higher non-hematologic toxicity attributable to treatment. This will exclude toxicities not caused by treatment, such as pain due to tumor progression. Toxicities will be defined per NCI CTCAE v5.0.
Measured: Until 30 days after ablation (up to 12 weeks on study)
Secondary outcomes (4)
Local Control Rate Per RECIST Criteria as Reported by Count of Participants
Radiologic response per RECIST criteria and volumetric measurements.
Measured: 8 weeks
Progression Free Survival
Measured: 8 weeks
Overall Survival
Measured: 8 weeks
Tumor Pathology of Post-SBRT Specimen (H&E Staining)
H\&E staining for percentage of viable tumor remaining as measured by the presence of necrosis, fibrosis, hyalinization, and/or calcification, compared to pre-SBRT pathology
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start28 Jun 2018
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Why it stopped: slow accrual
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 Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Bassetti, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782715
- Sponsor's protocol ID
- UW15103
- Other IDs
- 2016-0286, NCI-2016-00775, A533300, SMPH\HUMAN ONCOLOGY\HUMAN ONCO, Protocol Version 4/16/2019
- Status last verified
- Feb 2024
- First submitted
- 19 May 2016
- Last updated
- 20 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time MRI-Guided Stereotactic Body Radiation Therapy and Microwave Ablation for Non-Operable Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02782715
- Acronym / sponsor ID
- UW15103
- Conditions
- Carcinoma, Renal Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Posted 20 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims of this study are:
- To determine the safety and feasibility of treating patients with a combination of MRI guided stereotactic body radiation therapy and microwave ablation.
- To assess short and long-term toxicity rates of patients treated with a combined modality approach.
- To assess local control, survival, and pathologic response to treatment
Detailed description
Renal cell carcinoma is traditionally managed via a surgical approach. Increasingly, local therapy with radiofrequency and microwave ablation is being utilized as an alternative for patients who may not tolerate a nephrectomy or who refuse one. Although local control rates for small lesions are excellent, they drop off precipitously for lesions over 4 cm. Furthermore, lesions in critical areas such as the renal hilum may be difficult to treat with this method. Stereotactic body radiation therapy (SBRT) has had a long record of treating patients with inoperable tumors in locations such as the lung and central nervous system, and there is increasing evidence that it may be useful for patients with renal cell carcinoma. The recent emergence of MRI-guided radiation therapy allows for direct visualization of tumors during treatment, and may potentially allow clinicians to treat tumors more precisely. This phase I study will treat renal cell carcinoma patients using a combination of MRI-guided stereotactic body radiation therapy and microwave ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy & Microwave Ablation | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Procedure: Microwave Ablation (MWA)3+3 dose-escalation wherein three dose levels of stereotactic body radiation therapy (SBRT) would be evaluated: 1. Dose level I: 6 Gy x 5 fractions 2. Dose level II: 8 Gy x 5 fractions 3. Dose level III: 10 Gy x 5 fractions Radiation treatments will be delivered two to three times a week, with five fractions completed over two weeks. Four to six weeks after radiation treatment, patients will undergo repeat CT or MRI imaging to assess tumor response and suitability for microwave ablations. Eight weeks after the conclusion of SBRT, patients will undergo microwave ablation (approximately 12 weeks after registration). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with imaging findings consistent with renal cell carcinoma
- Deemed medically inoperable per urology evaluation
- Tumor size >4cm in largest dimension
- ECOG performance status of <2
- Signed informed consent document(s)
Key exclusion criteria (5 listed)
- Patients who fail MRI screening
- Pregnant or nursing women
- History of prior radiation therapy to the upper abdomen
- History of invasive cancer in the last 3 years (except for appropriately treated low-rist prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer)
- Treatment with a non-approved or investigational drug within 28 days of study treatment
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 Body Radiation Therapy (SBRT)Patients will be treated on study with a course of SBRT treatment by a radiation oncologist. Three SBRT dose levels targeting the primary tumor will be evaluated; level I: 6 Gy x 5 fractions (a common palliative dose), level II: 8 Gy x 5 fractions, and level III: 10 Gy x 5 fractions (a common definitive dose). | Radiation | Radiotherapy & Microwave Ablation |
| Microwave Ablation (MWA)Performed under sedation using ultrasound and computed tomography (CT) guidance for percutaneous antenna placement and confirmation. Depending on size and location of tumor, one to three antennas (Certus 140; NeuWave Medical) will be used. The system is an FDA-approved, high-powered third-generation MW device that uses CO2 gas cooling to prevent shaft heating. The gas cooling allows the probes to be stuck into tissue by creating a small ice ball at the tip using the Joule-Thomson method, similar to the tissue cooling mechanism of cryoablation systems. Probes are 17-gauge, and various ablation zone configurations are available depending on the probe selected. An ablation protocol using the 65W power setting for 5 minutes will be used for most patients. Ultrasound will be used for real-time monitoring of the extent of ablation to achieve a 5mm margin beyond tumor, and immediate post-procedure imaging performed using contrast-enhanced CT (CECT) for patients with adequate renal functions. | Procedure or surgery | Radiotherapy & Microwave Ablation |
Primary outcome
Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma
Time frame: Until 30 days after ablation (up to 12 weeks on study)
Dose-limiting toxicity (DLT) will be defined as grade 4 or higher non-hematologic toxicity attributable to treatment. This will exclude toxicities not caused by treatment, such as pain due to tumor progression. Toxicities will be defined per NCI CTCAE v5.0.
4 secondary outcomes
Local Control Rate Per RECIST Criteria as Reported by Count of Participants
Time frame: 8 weeks
Progression Free Survival
Time frame: 8 weeks
Overall Survival
Time frame: 8 weeks
Tumor Pathology of Post-SBRT Specimen (H&E Staining)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UW Carbone Cancer Center Home PageLink provided by the sponsor.
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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.
Michael Bassetti principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic Body Radiation Therapy (SBRT) and Microwave Ablation (MWA) in people with Carcinoma, Renal Cell, run by University of Wisconsin, Madison 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 20 Mar 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 20 Mar 2024). 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?
Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma (time frame: Until 30 days after ablation (up to 12 weeks on study)). 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 20 Mar 2024.