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Proton Beam Therapy
Proton Radiotherapy for Liver Cancer
Phase 2
Waitlist Available
Led By Jonathan B. Ashman, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage T0-T4N0M0 (American Joint Committee on Cancer [AJCC] 8th edition)
Minimum single lesion size >= 1 cm, maximum cumulative diameter =< 15 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will test whether proton radiotherapy is effective in treating patients with liver cancer.
Who is the study for?
Adults with newly diagnosed or recurrent liver cancer, specifically hepatocellular carcinoma without metastases. They can have up to three treatable lesions and may have had prior local treatments. Participants should be in relatively good health (ECOG 0-2), with a life expectancy of at least 3 months, adequate blood counts, and no severe illnesses that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing stereotactic body proton radiotherapy for liver cancer treatment. This non-invasive method uses precise high-energy proton beams aimed at tumors to minimize damage to surrounding healthy tissue. The study will assess its effectiveness and impact on patients' quality of life.See study design
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, fatigue, nausea, changes in appetite, abdominal pain or discomfort due to inflammation around the liver area. There might also be risks associated with radiation exposure such as damage to nearby organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is at an early or localized stage.
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My cancer has at least one tumor that is 1 cm or larger but all tumors together are not more than 15 cm in total.
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I have 1-3 liver lesions treatable with one radiation plan.
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I have been diagnosed with liver cancer, either for the first time or as a recurrence.
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I am 18 years old or older.
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My liver function is moderately to mildly impaired.
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My cancer can be treated with a specific type of radiation therapy using protons.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
3-month rate of patients experiencing an increase in Child-Pugh score by 2 or more points of 5-fraction stereotactic body proton radiotherapy in the treatment of hepatocellular carcinoma (HCC)
Secondary outcome measures
3-month complication rate
6-month local control
Imaging response rates
+5 moreOther outcome measures
Blood bank patient specimens for future analysis
Clinical features, treatment technique, and dose-volume parameters
Patient-reported outcomes
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (SBPT)Experimental Treatment2 Interventions
Patients undergo 1 SBPT fraction over 20-30 minutes per day for a total of 5 fractions.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,074 Total Patients Enrolled
8 Trials studying Hepatocellular Carcinoma
3,007 Patients Enrolled for Hepatocellular Carcinoma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,658 Total Patients Enrolled
44 Trials studying Hepatocellular Carcinoma
6,331 Patients Enrolled for Hepatocellular Carcinoma
Jonathan B. Ashman, M.D., Ph.D.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is at an early or localized stage.My cancer has at least one tumor that is 1 cm or larger but all tumors together are not more than 15 cm in total.I have 1-3 liver lesions treatable with one radiation plan.I have been diagnosed with liver cancer, either for the first time or as a recurrence.I am 18 years old or older.I am a woman who can have children and do not use birth control.My cancer involves blood vessels.I cannot receive radiotherapy due to health reasons.My liver has more than 3 highly likely cancerous lesions or too much disease for safe treatment.My cancer has spread beyond my liver.My platelet count is at least 30,000, possibly after receiving treatment to reach this level.I have had external beam radiation as preparation for a transplant.I have received radiation at the site of my current cancer, or more radiation there is deemed unsafe.My liver function is moderately to mildly impaired.My doctor believes I have at least 3 months to live considering my overall health and cancer stage.My cancer can be treated with a specific type of radiation therapy using protons.I cannot have CT or MRI scans with contrast due to medical reasons.I do not have any severe illnesses that would stop me from following the study rules.I have active systemic lupus or scleroderma.I can take care of myself and am up and about more than half of my waking hours.My hemoglobin level is at least 8.0 g/dL.I had liver treatment like surgery or ablation over 6 weeks ago.I haven't had any cancer besides skin cancer or in situ cancers treated locally in the past year.My cancer has spread to nearby organs or the main bile duct.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SBPT)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What adverse effects have been seen in people who undergo Proton Stereotactic Body Radiation Therapy?
"We assessed the safety of Proton Stereotactic Body Radiation Therapy to be a 2 as this is still in Phase 2, thus there are some evidence-based findings that suggest its security but not efficacy."
Answered by AI
What is the current projected sample size of this clinical trial?
"Yes, public records from clinicaltrials.gov demonstrate that this medical research initiative began recruiting patients on February 4th 2021 and has since been updated on May 11th 2022. The investigators aim to enroll 60 participants across two sites."
Answered by AI
Is this medical trial still accepting participants?
"Per documentation found on clinicaltrials.gov, this medical research is still open for enrollment and was last modified in May of 2022; it had initially been posted to the site 6 months prior."
Answered by AI
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