Primary TumorPhase 1NCT02410174
To Evaluate Stereotactic Body Radiotherapy for Treatment of Primary Renal Cell Carcinoma Tumors
A Phase 1 study testing Stereotactic Body Radiotherapy (SBRT) in people with Primary Tumor and Renal Cell Carcinoma, run by Beth Israel Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC) in medically inoperable patients and/or patients who refuse surgery. Standard treatment of RCC is surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Tumor, Renal Cell Carcinoma
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Dec 2016
- Phase
- Phase 1
- 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
- Any patient with a primary renal cell carcinoma (RCC) tumor who is inoperable for technical (i.e surgical) or medical reasons
- Patient must be screened by a urologic surgeon to verify eligibility on the above basis
- Biopsy proof of RCC is preferred; however, in current practice the diagnosis is often clinical based on characteristic imaging. If there are compelling clinical reasons not to proceed with biopsy, the clinical diagnosis will suffice.
- Patient with metastases are eligible if in the opinion of the treating physicians the patient could benefit from treatment of the primary renal tumor.
- ECOG performance status 0-2
- Age ≥18 years
- Signed informed consent
Who cannot join
- Inadequate renal function, as measured by creatinine clearance calculated from 24 hour urine collection. Creatinine clearance values of at least 50 ml/min are required
- Prior attempt at curative treatment of this primary kidney tumor
- Inability to lie still for approximately 1 hour in immobilization device
- Presence of a connective tissue disorder other than rheumatoid arthritis.
- Pregnancy
- Inability to develop a radiation treatment plan that adheres to the dose constraints described below in Radiotherapy Treatment Planning section.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai Beth Israel Hospital
New York, New York, 10003
Mount Sinai Roosevelt Hospital
New York, New York, 10014
About this study
Official title: Phase I Trial of Stereotactic Body Radiotherapy (SBRT) of the Primary Tumor in Renal Cell Carcinoma (RCC)
The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC) in medically inoperable patients and/or patients who refuse surgery. Standard treatment of RCC is surgery. A number of non-surgical treatments of RCC are also available, but are highly invasive and are associated with significant side effects. SBRT is a non-invasive, non-surgical treatment that requires tumor immobilization and image guidance in order to deliver a very precise, high-dose treatment. This trial will assess the use of SBRT to treat primary renal tumors by determining the maximum tolerated dose and toxicity. Subjects enrolled in this study will then be followed and evaluated for toxicity, serum chemistry, complete blood count, and urinalysis. In addition, they will undergo renal scans to assess the functionality of their renal tissue.
Read the detailed description
There is a need for a non-invasive treatment modality in renal cell carcinoma (RCC) patients who are medically or technically inoperable or refuse surgery. The primary tumor in patients with RCC is generally managed surgically or with a non-surgical ablative modality, but there is significant toxicity and invasiveness associated with current surgical and percutaneous treatment modalities. Stereotactic radiotherapy was first developed to treat brain metastases and other intracranial tumors by giving a single high-dose treatment delivered with a precision of less than 1 mm. This treatment requires immobilization of the tumor and precise imaging to guide the treatment. The brain is particularly amenable to this approach since there is no internal brain motion, the skull is easily fixed in position, and excellent imaging is available. Recent developments in immobilization and image guidance now permit precise tumor targeting of extracranial sites, such as the liver and lung. Stereotactic radiotherapy used at extracranial sites is called stereotactic body radiotherapy (SBRT). Because of the great precision of SBRT, a high dose per treatment is possible. Early work evaluating SBRT in primary and metastatic liver and lung tumors has shown excellent results in tumor control and toxicity. Based on this, we propose expanding the use of this technique to RCC.
In this study, the investigators seek to evaluate the safety and efficacy of SBRT for the treatment of the primary tumor in renal cell carcinoma (RCC). One goal of this study is to establish the maximum tolerated dose (MTD) of renal SBRT by determining the dose-volume relationship and toxicity for the kidney when high dose per fraction SBRT is used. In order to ensure proper immobilization and tumor localization, the investigators will use abdominal compression, 4D CT scanning at the time of simulation, and cone beam CT scanning at the time of treatment. The investigators propose to perform Tc-99m glucoheptonate renal scans before and after SBRT to assess renal tissue at the periphery of the lesion, as well as baseline and follow-up serum chemistry evaluation, creatinine, complete blood count, urinalysis, and creatinine clearance.
- Conditions
- Primary Tumor, Renal Cell Carcinoma
- Being tested
- Stereotactic Body Radiotherapy (SBRT)
- Keywords
- Renal Cell Carcinoma, RCC, Stereotactic Body Radiotherapy, SBRT
- 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 Radiotherapy (SBRT)Radiation
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Starting dose of 48Gy in 3 fractions, will escalate dose by 2 Gy per fraction (a 6Gy total dose) to a maximum dose of 20Gy x 3 fractions (TD 60 Gy in 3 fractions). Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Failure
A ≥20% increase in the sum of the diameters of the tumor with a minimum increase in the sum of 5 mm (RECIST criteria) or any areas of enhancement on follow up imaging studies is categorized as progression. Time to failure will be from the last date of SBRT to date of local failure or last follow-up.
- Local failure will be classified as in field if it occurs within the treated volume or marginal if it occurs at the edge of the treated volume.
- Development of a new renal tumor elsewhere in the kidney. This will not be considered a local failure. Time to development of a new tumor elsewhere in the kidney will be from the last date of SBRT to date of the event or last follow-up.
Measured: up to 10 years
Secondary outcomes (6)
Regional Nodal Failure
-Recurrence is renal hilar, para-aortic or para-caval lymph nodes.
Measured: up to 10 years
Metastases
Incidence of metastases
Measured: up to 10 years
Overall survival
Measured: up to 10 years
Serum Creatinine Level
Measured: 1 year
24 Hour Creatinine Clearance
Measured: 1 year
Results of Tc-99m Glucoheptonate Renal Scan
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startMay 2012
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Poor Accural
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary TumorStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald D Ennis, MD, Principal investigator, Mount Sinai Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410174
- Sponsor's protocol ID
- 100-11
- Status last verified
- Apr 2016
- First submitted
- 2 Apr 2015
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Stereotactic Body Radiotherapy (SBRT) of the Primary Tumor in Renal Cell Carcinoma (RCC)
- ClinicalTrials.gov ID
- NCT02410174
- Acronym / sponsor ID
- 100-11
- Conditions
- Primary Tumor, Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma, RCC, Stereotactic Body Radiotherapy, SBRT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor Accural
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Apr 2015 (estimated)
- 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.
The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC) in medically inoperable patients and/or patients who refuse surgery. Standard treatment of RCC is surgery. A number of non-surgical treatments of RCC are also available, but are highly invasive and are associated with significant side effects. SBRT is a non-invasive, non-surgical treatment that requires tumor immobilization and image guidance in order to deliver a very precise, high-dose treatment. This trial will assess the use of SBRT to treat primary renal tumors by determining the maximum tolerated dose and toxicity. Subjects enrolled in this study will then be followed and evaluated for toxicity, serum chemistry, complete blood count, and urinalysis. In addition, they will undergo renal scans to assess the functionality of their renal tissue.
Detailed description
There is a need for a non-invasive treatment modality in renal cell carcinoma (RCC) patients who are medically or technically inoperable or refuse surgery. The primary tumor in patients with RCC is generally managed surgically or with a non-surgical ablative modality, but there is significant toxicity and invasiveness associated with current surgical and percutaneous treatment modalities. Stereotactic radiotherapy was first developed to treat brain metastases and other intracranial tumors by giving a single high-dose treatment delivered with a precision of less than 1 mm. This treatment requires immobilization of the tumor and precise imaging to guide the treatment. The brain is particularly amenable to this approach since there is no internal brain motion, the skull is easily fixed in position, and excellent imaging is available. Recent developments in immobilization and image guidance now permit precise tumor targeting of extracranial sites, such as the liver and lung. Stereotactic radiotherapy used at extracranial sites is called stereotactic body radiotherapy (SBRT). Because of the great precision of SBRT, a high dose per treatment is possible. Early work evaluating SBRT in primary and metastatic liver and lung tumors has shown excellent results in tumor control and toxicity. Based on this, we propose expanding the use of this technique to RCC.
In this study, the investigators seek to evaluate the safety and efficacy of SBRT for the treatment of the primary tumor in renal cell carcinoma (RCC). One goal of this study is to establish the maximum tolerated dose (MTD) of renal SBRT by determining the dose-volume relationship and toxicity for the kidney when high dose per fraction SBRT is used. In order to ensure proper immobilization and tumor localization, the investigators will use abdominal compression, 4D CT scanning at the time of simulation, and cone beam CT scanning at the time of treatment. The investigators propose to perform Tc-99m glucoheptonate renal scans before and after SBRT to assess renal tissue at the periphery of the lesion, as well as baseline and follow-up serum chemistry evaluation, creatinine, complete blood count, urinalysis, and creatinine clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT)Starting dose of 48Gy in 3 fractions, will escalate dose by 2 Gy per fraction (a 6Gy total dose) to a maximum dose of 20Gy x 3 fractions (TD 60 Gy in 3 fractions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Any patient with a primary renal cell carcinoma (RCC) tumor who is inoperable for technical (i.e surgical) or medical reasons
- Patient must be screened by a urologic surgeon to verify eligibility on the above basis
- Biopsy proof of RCC is preferred; however, in current practice the diagnosis is often clinical based on characteristic imaging. If there are compelling clinical reasons not to proceed with biopsy, the clinical diagnosis will suffice.
- Patient with metastases are eligible if in the opinion of the treating physicians the patient could benefit from treatment of the primary renal tumor.
- ECOG performance status 0-2
Key exclusion criteria (6 listed)
- Inadequate renal function, as measured by creatinine clearance calculated from 24 hour urine collection. Creatinine clearance values of at least 50 ml/min are required
- Prior attempt at curative treatment of this primary kidney tumor
- Inability to lie still for approximately 1 hour in immobilization device
- Presence of a connective tissue disorder other than rheumatoid arthritis.
- Pregnancy
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 Radiotherapy (SBRT) | Radiation | Stereotactic Body Radiotherapy (SBRT) |
Primary outcome
Local Failure
Time frame: up to 10 years
A ≥20% increase in the sum of the diameters of the tumor with a minimum increase in the sum of 5 mm (RECIST criteria) or any areas of enhancement on follow up imaging studies is categorized as progression. Time to failure will be from the last date of SBRT to date of local failure or last follow-up. * Local failure will be classified as in field if it occurs within the treated volume or marginal if it occurs at the edge of the treated volume. * Development of a new renal tumor elsewhere in the kidney. This will not be considered a local failure. Time to development of a new tumor elsewhere in the kidney will be from the last date of SBRT to date of the event or last follow-up.
6 secondary outcomes
Regional Nodal Failure
Time frame: up to 10 years
Metastases
Time frame: up to 10 years
Overall survival
Time frame: up to 10 years
Serum Creatinine Level
Time frame: 1 year
24 Hour Creatinine Clearance
Time frame: 1 year
Results of Tc-99m Glucoheptonate Renal Scan
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Poor Accural). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
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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.
Ronald D Ennis, MD principal investigator
Mount Sinai Beth Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Body Radiotherapy (SBRT) in people with Primary Tumor and Renal Cell Carcinoma, run by Beth Israel Medical Center at 2 sites 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 7 inclusion and 6 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 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
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 was stopped early (reason given: Poor Accural). Results are not available in the source record.
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?
Local Failure (time frame: up to 10 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 9 Jan 2017.