Radiation Therapy for Liver Cancer

Recruiting in Palo Alto (17 mi)

Eugene J. Koay | MD Anderson Cancer Center

Overseen byEugene J. Koay

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and the best dose of radiation therapy in treating patients with hepatocellular carcinoma, cholangiocarcinoma, or cancer that has spread from the original (primary) tumor to the liver who also have impaired liver function (liver damage caused by cirrhosis, chemotherapy, or surgery). Radiation therapy (RT) uses high energy x-rays to kill tumor cells and shrink tumors. New methods of giving RT to the liver may help control cancer.

Research Team

Eugene J. Koay

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with liver cancer, bile duct cancer, or tumors that have spread to the liver and also have impaired liver function. Participants must have at least 400 ml of functional liver tissue and an ECOG performance status of 0-2. Women who can bear children should use contraception and not breastfeed. Those with recent heart issues, active hepatitis, infections, inflammatory bowel disease or another active malignancy are excluded.

Inclusion Criteria

Signed study-specific consent form

I had liver radiation therapy over 6 months ago for Y90 or over 12 months for others.

I have one or more tumors.

See 11 more

Exclusion Criteria

I currently have a fever or an untreated infection.

I do not have active hepatitis.

My inflammatory bowel disease is not well-managed.

See 8 more

Treatment Details

Interventions

Radiation Therapy (Radiation Therapy)

Trial OverviewThe study is testing different doses of radiation therapy to find the safest and most effective dose for patients with specific types of liver cancers and compromised liver function. It includes biomarker analysis, MRI scans, surveys on health status, alongside the radiation treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (radiation therapy)Experimental Treatment4 Interventions

Patients undergo radiation therapy 5 days a week for a total of 15 or 25 fractions in the absence of disease progression or unacceptable toxicity.

Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications: