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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
Cohort 3: History of prior liver-directed radiation therapy with either fractionated external beam radiation therapy (EBRT), stereotactic body radiation therapy (SBRT) or yttrium-90 radioembolization (Y90 RE); the interval between prior EBRT and re-irradiation on protocol should be equal to or greater than 12 months; the interval between prior Y90 RE and re-irradiation on protocol should be equal to or greater than 6 months;
Patients may have single or multinodular tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I had liver radiation therapy over 6 months ago for Y90 or over 12 months for others.
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I have one or more tumors.
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I may be taking capecitabine or sorafenib as part of my treatment.
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I have had surgery, chemotherapy, TACE, or radiofrequency ablation before.
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I can become pregnant and agree to use birth control and not breastfeed.
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My cancer treatment plan meets the required radiation dose limits.
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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've had liver surgery, chemotherapy with irinotecan or oxaliplatin, and at least 400 ml of healthy liver.
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I can take care of myself and am up and about more than half of the day.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum dose constraint
Secondary outcome measures
Local disease control rate
Overall survival
Patterns of failure
+1 more
Other outcome measures
Tumor biomarker expression in serum

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
~1310
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,413 Total Patients Enrolled
22 Trials studying Liver Cancer
9,411 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,610 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Eugene J KoayPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
294 Total Patients Enrolled

Media Library

Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02626312 — Phase 1
Liver Cancer Research Study Groups: Treatment (radiation therapy)
Liver Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are included in the current research?

"Affirmative. The information available on clinicaltrials.gov reveals that recruitment is ongoing for this research endeavour, which was first posted in February 15th 2016 and last edited June 16th 2021. 88 participants will be accepted from 1 site to take part in the trial."

Answered by AI

Has Radiotherapy been validated by the FDA?

"Due to limited data on its efficacy and safety, Radiation Therapy earned a score of 1."

Answered by AI

Are there any patients being enrolled in this research endeavor at present?

"Affirmative, the data shared on clinicaltrials.gov verifies that this medical trial is actively enrolling members. The study was initially posted February 15th 2016 and last modified June 16 2021. A total of 88 patients are needed from one centre."

Answered by AI
~0 spots leftby Apr 2024