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Photon Therapy

Proton vs Photon Therapy for Liver Cancer

Phase 3

Recruiting

Led By Theodore Hong

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have Child-Turcotte-Pugh (CTP) A or B7

Pathologically (histologically or cytologically) or radiographically-proven unresectable or locally recurrent hepatocellular cancer

Must not have

Uncontrolled prior invasive malignancy

Prior radiotherapy to study cancer region

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization to the date of death due to any cause or date of last follow-up for alive patients. this analysis occurs after 125 deaths have been observered; estimated to occurs around 5 years.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares proton therapy to photon therapy in treating liver cancer. Proton therapy may cause less damage to healthy organs and result in better survival.

Who is the study for?

This trial is for adults with liver cancer who have up to three tumors, meeting specific size requirements. They must have adequate organ function, may have had previous treatments like chemotherapy or surgery, and need a performance status showing they can carry out daily activities. Pregnant women or those not using contraception are excluded.

What is being tested?

The study compares two types of radiation therapy: photon therapy (high energy x-rays) and proton therapy (proton particles). Proton therapy might cause less damage to healthy organs around the tumor and potentially improve survival rates in liver cancer patients.

What are the potential side effects?

Radiation therapies like photons and protons could lead to fatigue, skin reactions at the treatment site, nausea, potential damage to surrounding healthy tissue resulting in organ dysfunction, but specifics will vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver function is classified as CTP A or B7.

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My liver cancer cannot be removed by surgery.

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I have up to 3 tumors that meet the size criteria.

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My cancer stage fits the study requirements based on recent scans.

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My cancer can be measured by tests.

Exclusion Criteria

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

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I have a history of cancer that is not currently under control.

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I have had radiation therapy on the cancer area being studied.

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I cannot confirm if my insurance covers the treatment.

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I have had a liver transplant.

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My cancer has spread outside the liver.

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I am HIV positive with a CD4 count below 200.

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I haven't had chemotherapy in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization to the date of death due to any cause or date of last follow-up for alive patients. this analysis occurs after 125 deaths have been observered; estimated to occurs around 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization to the date of death due to any cause or date of last follow-up for alive patients. this analysis occurs after 125 deaths have been observered; estimated to occurs around 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to the date of death due to any cause or date of last follow-up for alive patients. this analysis occurs after 125 deaths have been observered; estimated to occurs around 5 years. for reporting.