Renal Cell CarcinomaNCT01890590
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
A study testing CyberKnife in people with Renal Cell Carcinoma, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the efficacy of radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- CyberKnife
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2025
- Phase
- Interventional
- 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
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically or radiological evidence of Stage I (T1N0M0) renal cell carcinoma with a size no larger than 8 cm in greatest dimension measured by MRI or CT Scan
- At least one (usually up to 3) gold fiducial placed in or around tumor, can be performed on the same day - after signing research informed consent.
- No irreversible coagulopathies
- Age ≥ 18 years old because no dosing or adverse event data are currently available on the use of Cyberknife Radiosurgery radiation in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric Phase II trials.
- ECOG Performance Status ≤2 (Appendix A).
Show all 13Show fewer
- At least 12 month life expectancy
- Ability to have CT and/or MRI imaging with or without contrast and must be performed within 120 days prior to registration.
- No other cancer in previous 2 years with the exception of non-invasive skin cancers
- All subjects meeting eligibility criteria irrespective of gender, minority or other underrepresented status will be eligible for enrollment into the study.
- The effects of Cyberknife Radiosurgery on the developing human fetus are unknown. For this reason and because Radiation is known to be teratogenic, 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 the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document and study specific consent form prior to study entry.
- Labs: Serum Creatinin <3 mg/dl, Urinalysis, INR <2, PTT <70 sec, AST, ALT ≤2.5x ULN, Abnormalities on urinalysis (i.e. proteinuria) will not exclude patients from participation on study.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Irreversible coagulopathies that preclude fiducial placement
- Prior upper abdominal external beam irradiation
- Prior history of invasive malignancy within the last 2 years
- Inability to deliver target dose with CyberKnife due to inability to image fiducials
- Inability to deliver target dose with CyberKnife due to normal tissue dose constraints
- Inability to have contrast CT or MRI to help define tumor volume for radiation planning
- Decreased platelet count and / or anticoagulation parameters that would preclude transcutaneous placement of fiducials
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Irving D Kaplan, MD, 617-667-2345, ikaplan@caregroup.harvard.edu
Kaitlyn Scott-Haughey, M.Ed., 617-975-7408, kmscotth@bidmc.harvard.edu
About this study
CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the efficacy of radiation treatment. Currently, radiosurgery is commonly used for brain metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of clinically localized primary renal cell carcinoma.
Read the detailed description
Before the research starts (screening) Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about your health, current medications, and any allergies.
- Performance status, which evaluates how you are able to carry on with your usual activities.
- Quality of life survey.
- Gold seed (Fiducial) Placement: Placement of at least one (usually up to 3) gold fiducial(s) must be placed in or around the tumor by a surgeon or interventional radiologist a minimum of one week or more prior to pre-treatment planning simulation.
- An assessment of your tumor by X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.
- Blood tests.
- Urine test.
- You will undergo a simulation of the intervention procedure. It will involve the study team helping you position yourself for the study procedure as you undergo a CT scan of the abdomen while holding the correct position.
If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
After the screening procedures confirm that you are eligible to participate in the research study:
You will receive a series of Cyberknife Radiosurgery treatments, with the amount of radiation dosing adjusted for the size of your tumor. The treatment will ideally take place over the course of 3-4 days, but not more than 14 days overall.
You will be positioned in a stable position laying on your back, capable for reproducibility of positioning and not allowing you to move from simulation to treatment, allowing you to feel as comfortable as possible. A variety of systems may be utilized to keep you still; including vacuum bag, alpha cradle, or stereotactic frames that surround you on three sides and large rigid pillows conforming to your body.
After the final dosing We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study.
- Conditions
- Renal Cell Carcinoma
- Being tested
- CyberKnife
- Keywords
- Renal Cell Carcinoma, Cyberknife
- 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.
CyberKnifeDevice
Also called SBRT
Stereotactic Body Radiation Therapy. 3 or 4 fractions of radiotherapy delivered by Cyberknife.
| Study group | Role | What they receive |
|---|---|---|
| Cyberknife | Experimental | You will receive a series of Cyberknife Radiosurgery treatments, with the amount of radiation dosing adjusted for the size of your tumor. The treatment will ideally take place over the course of 3-4 days, but not more than 14 days overall. (3 or 4 fractions of radiation therapy delivered by cyberknife) Receives: Device: CyberKnife |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months
To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months
Measured: 2 Years
Secondary outcomes (2)
To determine impact of therapy on quality of life.
To determine impact of therapy on quality of life.
Measured: 2 Years
To evaluate adverse events.
To evaluate adverse events.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess 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
- Model description
- Cyberknife treatment
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Irving Kaplan, Beth Israel Deaconess Medical Center
- Investigators
- Irving D Kaplan, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890590
- Sponsor's protocol ID
- 12-235
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2013
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01890590
- Acronym / sponsor ID
- 12-235
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma, Cyberknife
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- Jul 2013 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 2 Jul 2013 (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.
CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the efficacy of radiation treatment. Currently, radiosurgery is commonly used for brain metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of clinically localized primary renal cell carcinoma.
Detailed description
Before the research starts (screening) Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about your health, current medications, and any allergies.
- Performance status, which evaluates how you are able to carry on with your usual activities.
- Quality of life survey.
- Gold seed (Fiducial) Placement: Placement of at least one (usually up to 3) gold fiducial(s) must be placed in or around the tumor by a surgeon or interventional radiologist a minimum of one week or more prior to pre-treatment planning simulation.
- An assessment of your tumor by X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.
- Blood tests.
- Urine test.
- You will undergo a simulation of the intervention procedure. It will involve the study team helping you position yourself for the study procedure as you undergo a CT scan of the abdomen while holding the correct position.
If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
After the screening procedures confirm that you are eligible to participate in the research study:
You will receive a series of Cyberknife Radiosurgery treatments, with the amount of radiation dosing adjusted for the size of your tumor. The treatment will ideally take place over the course of 3-4 days, but not more than 14 days overall.
You will be positioned in a stable position laying on your back, capable for reproducibility of positioning and not allowing you to move from simulation to treatment, allowing you to feel as comfortable as possible. A variety of systems may be utilized to keep you still; including vacuum bag, alpha cradle, or stereotactic frames that surround you on three sides and large rigid pillows conforming to your body.
After the final dosing We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cyberknife treatment
| Arm | Type | Receives |
|---|---|---|
| Cyberknife | Experimental | Device: CyberKnifeYou will receive a series of Cyberknife Radiosurgery treatments, with the amount of radiation dosing adjusted for the size of your tumor. The treatment will ideally take place over the course of 3-4 days, but not more than 14 days overall. (3 or 4 fractions of radiation therapy delivered by cyberknife) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically or radiological evidence of Stage I (T1N0M0) renal cell carcinoma with a size no larger than 8 cm in greatest dimension measured by MRI or CT Scan
- At least one (usually up to 3) gold fiducial placed in or around tumor, can be performed on the same day - after signing research informed consent.
- No irreversible coagulopathies
- Age ≥ 18 years old because no dosing or adverse event data are currently available on the use of Cyberknife Radiosurgery radiation in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric Phase II trials.
Key exclusion criteria (8 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Irreversible coagulopathies that preclude fiducial placement
- Prior upper abdominal external beam irradiation
- Prior history of invasive malignancy within the last 2 years
- Inability to deliver target dose with CyberKnife due to inability to image fiducials
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 |
|---|---|---|
| CyberKnifeAlso: SBRTStereotactic Body Radiation Therapy. 3 or 4 fractions of radiotherapy delivered by Cyberknife. | Device | Cyberknife |
Primary outcome
To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months
Time frame: 2 Years
To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months
2 secondary outcomes
To determine impact of therapy on quality of life.
Time frame: 2 Years
To evaluate adverse events.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- 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.
Irving D Kaplan, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife in people with Renal Cell Carcinoma, run by Beth Israel Deaconess 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 13 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Aug 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irving D Kaplan, MD (617-667-2345, ikaplan@caregroup.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months (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 15 Aug 2024.