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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

Must not have

Women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception

Medical contraindication to receipt of radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman who can have children and do not use birth control.

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I cannot receive radiotherapy due to health reasons.

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My liver has more than 3 highly likely cancerous lesions or too much disease for safe treatment.

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My cancer has spread beyond my liver.

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I have received radiation at the site of my current cancer, or more radiation there is deemed unsafe.

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I cannot have CT or MRI scans with contrast due to medical reasons.

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I do not have any severe illnesses that would stop me from following the study rules.

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I have active systemic lupus or scleroderma.

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My cancer has spread to nearby organs or the main bile duct.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

3-month complication rate

6-month local control

Imaging response rates

+5 more

Other study objectives

Clinical features, treatment technique, and dose-volume parameters

Patient-reported outcomes

Value of additional imaging analyses and techniques