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Radiation Therapy
SBRT for Liver Cancer (vGRID SBRT Trial)
N/A
Recruiting
Led By David Akhavan, MD
Research Sponsored by University of Kansas 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 end of treatment through 3 month post-radiation
Awards & highlights
vGRID SBRT Trial Summary
This trial tests a new radiation therapy to treat liver tumors with low toxicity and higher doses than current methods.
Who is the study for?
This trial is for adults with unresectable or metastatic hepatocellular carcinoma (liver cancer) who have adequate blood counts, liver and kidney function, and are not pregnant. They must agree to use contraception and cannot be eligible for a transplant or have severe active comorbidities like heart failure, uncontrolled bleeding, or infections.Check my eligibility
What is being tested?
The trial is testing the maximum tolerated dose of Stereotactic Body Radiation Treatment (SBRT) using vGRID therapy technique on liver tumors. It aims to find out how much radiation can be given safely while monitoring the side effects.See study design
What are the potential side effects?
Potential side effects may include typical reactions to high-dose radiation such as fatigue, skin reactions in the treated area, nausea, vomiting, abdominal pain, and potential damage to nearby organs like the stomach or intestines.
vGRID SBRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of treatment through 3 month post-radiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment through 3 month post-radiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of Single Fraction GRID SBRT
Secondary outcome measures
Local control utilizing RECIST v1.1 for HCC.
Molecular correlatives: TCR repertoire analysis.
Progression free survival (PFS)
+2 morevGRID SBRT Trial Design
1Treatment groups
Experimental Treatment
Group I: Single fraction SBRT 27 GyExperimental Treatment1 Intervention
vGRID SBRT 3+3 dose escalation, single fraction, one day cycle length
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Who is running the clinical trial?
VarianUNKNOWN
4 Previous Clinical Trials
408 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
60 Previous Clinical Trials
3,766 Total Patients Enrolled
University of Kansas Medical CenterLead Sponsor
470 Previous Clinical Trials
171,404 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver cancer is operable or suitable for a transplant.I, or my legal representative, can understand the study and agree to sign the consent form.I agree not to donate sperm during and for 12 months after the study.I am 18 years old or older.My liver cancer is confirmed and has spread or is advanced.I will not donate blood during or after the study.I am currently taking drugs that suppress my immune system.I do not have another active cancer except for certain types.I haven't had major surgery, organ transplant, uncontrolled high blood pressure, severe fluid buildup, abdominal issues, active autoimmune disease, immune system problems, recent steroid treatment, or significant bleeding recently.I cannot have surgery or a transplant for my condition.My liver cancer cannot be removed by surgery and has spread.My cancer has spread to specific areas.My blood, liver, and kidney tests are within normal ranges.I have had radiation therapy to my abdomen before.My liver function is classified as Child Pugh A to B7.I am fully active or can carry out light work.I have been diagnosed with bile duct cancer.I agree to either not have sex or use birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Single fraction SBRT 27 Gy
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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