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Y-90 Radioembolization for Liver Cancer
Phase 1
Recruiting
Led By Ching-Wei Tzeng, MD
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
Received at least four cycles (or two months) of chemotherapy
Be older than 18 years old
Must not have
Symptomatic primary colon or rectal cancer (without pre-existing proximal diverting ostomy)
Other medical or clinical contraindications to liver surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a treatment called Y-90 TARE can help control tumors on the right side of the liver, and if it can induce hypertrophy (growth) of the left liver as part of a planned hepatectomy.
Who is the study for?
This trial is for patients with colorectal liver metastases (CLM) who need surgery but have insufficient future liver remnant (FLR). Candidates must be medically fit for operation, mentally competent to consent, and have potentially curable CLM without extensive extrahepatic disease. They should not be pregnant or breastfeeding, nor suffer from conditions like high bilirubin levels, low platelets, albumin deficiency, portal hypertension or cirrhosis.
What is being tested?
The study tests the safety of Y-90 TARE (radioembolization) in controlling tumors on one side of the liver and stimulating growth in the other part before a major hepatectomy. It's designed for those whose FLR is too small initially and aims to make a single-stage or two-stage liver resection possible.
What are the potential side effects?
Y-90 resin microspheres may cause abdominal pain, nausea, fatigue post-treatment known as 'post-radioembolization syndrome', potential damage to nearby organs due to radiation exposure such as ulcers if it affects the stomach lining.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed at least four cycles or two months of chemotherapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have symptoms from colon or rectal cancer and do not have an ostomy.
Select...
I have no medical reasons preventing me from having liver surgery.
Select...
I have significant difficulty with my daily activities due to my health.
Select...
My cancer has worsened on scans or blood tests after 4 chemotherapy cycles, making surgery not an option.
Select...
My liver's future remaining portion is expected to be less than 20% before treatment.
Select...
I have portal hypertension or cirrhosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: Yttrium-90Experimental Treatment1 Intervention
Help to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,277 Total Patients Enrolled
Sirtex MedicalIndustry Sponsor
29 Previous Clinical Trials
4,238 Total Patients Enrolled
Ching-Wei Tzeng, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms from colon or rectal cancer and do not have an ostomy.I am mentally capable and willing to sign a consent form.My surgeon says I am fit for surgery.I have no medical reasons preventing me from having liver surgery.I need a procedure to prepare my liver for a major surgery aimed at curing me.I have cancer outside the liver that cannot be treated with the intent to cure, except for treatable primary tumor and lung metastases.I have significant difficulty with my daily activities due to my health.My cancer has worsened on scans or blood tests after 4 chemotherapy cycles, making surgery not an option.My colorectal cancer has spread to my liver, but surgery might still be possible.My liver's future remaining portion is expected to be less than 20% before treatment.I have portal hypertension or cirrhosis.I have completed at least four cycles or two months of chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Yttrium-90
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.