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Radiation Therapy

Radiation Therapy for Liver Cancer

Phase 1
Waitlist Available
Led By Eugene J Koay
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Compromised liver function as defined by any of the following: Cohort 1: Advanced cirrhosis group, Borderline Child-Pugh class A6, Child-Pugh class B, The patients in this advanced cirrhosis group must have at least 400 ml of functional liver, as estimated on either diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) or single photon emission computed tomography (SPECT)/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients
Cirrhosis group: Child-Pugh class A5; Borderline Child-Pugh class A6; The patients in this group must have at least 400 ml of functional liver, as estimated on either diagnostic imaging (CT or MRI) or SPECT/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients
Must not have
Current evidence of fever or untreated infection
Active hepatitis, including but not limited to viral and drug-induced
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the side effects and best dose of radiation therapy in treating patients with liver cancer that has spread or caused liver damage.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Radiation therapy may cause side effects such as fatigue, skin reactions in treated areas (redness or irritation), nausea or vomiting, loss of appetite, inflammation in surrounding organs like the lungs (radiation pneumonitis), changes in blood counts leading to increased risk of infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is not working well due to advanced cirrhosis.
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I have mild liver cirrhosis with enough healthy liver tissue.
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I have had liver surgery or certain chemotherapies but still have at least 400 ml of healthy liver.
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I have been diagnosed with liver cancer or liver metastasis.
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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have a fever or an untreated infection.
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I do not have active hepatitis.
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My inflammatory bowel disease is not well-managed.
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I have had radiation therapy targeted at my liver.
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My liver function score is over 6, and I've had liver radiation.
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I am currently pregnant.

Timeline

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
Maximum dose constraint
Secondary study objectives
Local disease control rate
Overall survival
Patterns of failure
+1 more
Other study objectives
Tumor biomarker expression in serum

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,772 Total Patients Enrolled
14 Trials studying Cholangiocarcinoma
3,975 Patients Enrolled for Cholangiocarcinoma
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,134 Total Patients Enrolled
107 Trials studying Cholangiocarcinoma
10,943 Patients Enrolled for Cholangiocarcinoma
Eugene J KoayPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
307 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
2 Patients Enrolled for Cholangiocarcinoma

Media Library

Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02626312 — Phase 1
Cholangiocarcinoma Research Study Groups: Treatment (radiation therapy)
Cholangiocarcinoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT02626312 — Phase 1
Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02626312 — Phase 1
~5 spots leftby Apr 2026
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