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Radiation Therapy
CyberKnife for Kidney Cancer
N/A
Recruiting
Led By Irving D Kaplan, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether radiosurgery can effectively treat renal cell carcinoma while minimizing damage to nearby healthy tissue.
Who is the study for?
This trial is for adults with Stage I renal cell carcinoma (kidney cancer) no larger than 8 cm, who can have a gold marker placed near the tumor and are expected to live at least another year. They must not have had other cancers in the last 2 years (except non-invasive skin cancers), be able to undergo CT/MRI scans, and use contraception.
What is being tested?
The study tests CyberKnife Radiosurgery's effectiveness on localized kidney cancer. This technology delivers high radiation doses directly to tumors while sparing nearby organs, potentially increasing treatment success.
What are the potential side effects?
While specific side effects of CyberKnife for kidney cancer aren't detailed here, radiosurgery may cause fatigue, skin reactions at the treatment site, nausea or discomfort during or after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months
Secondary study objectives
To determine impact of therapy on quality of life.
To evaluate adverse events.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CyberknifeExperimental Treatment1 Intervention
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CyberKnife
2009
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteOTHER
1,108 Previous Clinical Trials
357,191 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
855 Previous Clinical Trials
12,930,915 Total Patients Enrolled
Irving D Kaplan, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that prevents the placement of fiducials due to blood clotting issues.You have received radiation therapy in your upper abdomen before.You have had another type of cancer in the past 2 years.You have a good level of physical ability, with minimal limitations in daily activities.You are expected to live for at least 12 more months.Your body cannot handle the prescribed dose of radiation with CyberKnife because it might harm healthy tissues.You cannot have a special type of CT or MRI scan to help plan radiation treatment for your tumor.Your blood is not able to clot properly or your platelet count is low, making it difficult to safely place fiducials through the skin.You have evidence from a biopsy or imaging showing early stage kidney cancer that is no larger than 8 cm.You do not have any permanent blood clotting disorders.You cannot receive the planned treatment dose using CyberKnife because the fiducial markers cannot be seen in imaging.Your kidney function, blood clotting, and liver function tests are within normal range. Any protein in your urine will not prevent you from joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cyberknife
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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