- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01890590
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Irving D Kaplan, MD
- Phone Number: 617-667-2345
- Email: ikaplan@caregroup.harvard.edu
Study Contact Backup
- Name: Kaitlyn Scott-Haughey, M.Ed
- Phone Number: 617-975-7408
- Email: kmscotth@bidmc.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconess Medical Center
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Contact:
- Irving D Kaplan, MD
- Phone Number: 617-667-2345
- Email: ikaplan@caregroup.harvard.edu
-
Contact:
- Kaitlyn Scott-Haughey, M.Ed.
- Phone Number: 617-975-7408
- Email: kmscotth@bidmc.harvard.edu
-
Principal Investigator:
- Irving D Kaplan, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cyberknife
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)
|
Stereotactic Body Radiation Therapy. 3 or 4 fractions of radiotherapy delivered by Cyberknife.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months
|
2 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine impact of therapy on quality of life.
Time Frame: 2 Years
|
To determine impact of therapy on quality of life.
|
2 Years
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To evaluate adverse events.
Time Frame: 2 years
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To evaluate adverse events.
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2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Irving D Kaplan, MD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Cell Carcinoma
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Unresectable Renal Cell... and other conditionsUnited States
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Australian and New Zealand Urogenital and Prostate...RecruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11.2 Translocation-Related Renal Cell CarcinomaAustralia
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National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell CarcinomaUnited States
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Bradley A. McGregor, MDBristol-Myers Squibb; ExelixisRecruitingRenal Cell Carcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Collecting Duct Renal Cell Carcinoma | Translocation Renal Cell Carcinoma | Unresectable Advanced Renal Cell Carcinoma | Metastatic Ncc Renal Cell CarcinomaUnited States
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National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Type 1 Papillary Renal Cell Carcinoma | Type 2 Papillary Renal Cell CarcinomaUnited States, Taiwan, Australia
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Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWithdrawnMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Unresectable Renal Cell Carcinoma | Hereditary Leiomyomatosis and Renal Cell Carcinoma | Clear Cell Papillary Renal Neoplasm | Hereditary Papillary Renal Cell Carcinoma and other conditionsUnited States
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingChromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma | Fumarate Hydratase Deficient Renal Cell Carcinoma | Succinate Dehydrogenase Deficient Renal Cell Carcinoma | Collecting Duct Renal...United States
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Australian and New Zealand Urogenital and Prostate...Bristol-Myers SquibbActive, not recruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11 Translocation CarcinomaAustralia
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Peloton Therapeutics, Inc.Active, not recruitingKidney Cancer | Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma (RCC) | Renal Cell Cancer Metastatic | Kidney | Clear Cell Renal Cell Carcinoma (ccRCC) | Renal Cell Carcinoma Recurrent | Renal Cell Cancer, RecurrentUnited States
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AmgenCompletedRenal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | Clear Cell Renal Carcinoma | Renal Cell AdenocarcinomaFrance, United States, Germany
Clinical Trials on CyberKnife
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Community Cancer Center, Normal, IllinoisUnknownProstate Cancer | Prostate Neoplasm | Cancer of the ProstateUnited States
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Accuray IncorporatedM.D. Anderson Cancer CenterTerminatedNon-small Cell Lung CancerFrance, United States, China, Taiwan
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Community Cancer Center, Normal, IllinoisCompletedTumor, Benign, Optic NerveUnited States
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Accuray IncorporatedCompletedProstatic Neoplasms | Prostate Cancer | Prostate Neoplasms | Cancer of the Prostate | Prostatic CancerUnited States
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Accuray IncorporatedCompletedProstatic Neoplasms | Prostate Cancer | Prostate Neoplasms | Cancer of the Prostate | Prostatic CancerUnited States
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Riverside Community Hospital, CaliforniaUnknownProstate CancerUnited States
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Boston Medical CenterActive, not recruitingProstate CancerUnited States
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Centre Francois Baclesse, LuxembourgActive, not recruiting
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Beth Israel Deaconess Medical CenterTerminated
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Capital Health System, IncRecruitingPancreas AdenocarcinomaUnited States