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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
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreOther 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
~1190
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,472 Total Patients Enrolled
22 Trials studying Liver Cancer
9,411 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,335 Total Patients Enrolled
105 Trials studying Liver Cancer
26,811 Patients Enrolled for Liver Cancer
Eugene J KoayPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
294 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had liver radiation therapy over 6 months ago for Y90 or over 12 months for others.I have one or more tumors.I may be taking capecitabine or sorafenib as part of my treatment.I have had surgery, chemotherapy, TACE, or radiofrequency ablation before.I can become pregnant and agree to use birth control and not breastfeed.I currently have a fever or an untreated infection.I do not have active hepatitis.My inflammatory bowel disease is not well-managed.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer or early prostate cancer with stable PSA levels.My cancer treatment plan meets the required radiation dose limits.I have mild liver cirrhosis with enough healthy liver tissue.I have had radiation therapy targeted at my liver.My liver is not working well due to advanced cirrhosis.I have had liver surgery or certain chemotherapies but still have at least 400 ml of healthy liver.My liver function score is over 6, and I've had liver radiation.My liver function score is either below 6 or above 9, and I haven't had radiation before.You are expected to live for at least 3 more months.I haven't had a severe heart condition or heart attack in the last 6 months.I have been diagnosed with liver cancer or liver metastasis.I've had liver surgery, chemotherapy with irinotecan or oxaliplatin, and at least 400 ml of healthy liver.I can take care of myself and am up and about more than half of the day.I have had yttrium-90 therapy before.I am currently pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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