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Radiation
SIRT with Y-90 Microspheres for Liver Cancer (DOORwaY90 Trial)
N/A
Recruiting
Led By Armeen Mahvash, M.D.
Research Sponsored by Sirtex Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance score of ≤1 at baseline
Age 18 or older at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months
Awards & highlights
DOORwaY90 Trial Summary
This trial is designed to study the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C.
Who is the study for?
This trial is for adults with unresectable hepatocellular carcinoma (HCC) who have not had prior cancer treatments and whose liver function is relatively preserved. They should have a life expectancy of more than 3 months, measurable tumors by imaging, and be able to consent. Exclusions include those with extrahepatic disease, history of severe allergies or other cancers under active treatment, certain blood disorders, drug/alcohol dependency, or conditions affecting study participation.Check my eligibility
What is being tested?
The trial tests SIR-Spheres Y-90 resin microspheres as a first-line treatment for local control of HCC in patients at various stages (BCLC A-C). These tiny beads deliver targeted radiation directly to the liver tumors. The goal is to assess safety and effectiveness compared to standard treatments.See study design
What are the potential side effects?
Potential side effects may include abdominal pain or discomfort post-procedure, nausea, fatigue due to radiation exposure; there's also a risk of inflammation in the liver or nearby organs from radiation damage. Rarely complications like ulcers or gastrointestinal bleeding can occur if microspheres inadvertently reach other areas.
DOORwaY90 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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My liver cancer diagnosis was confirmed by specific imaging or tissue analysis.
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I had liver surgery with clear margins, no tiny vessel invasion, and no new or returning cancer for 6 months.
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I had a small tumor treated without surgery and it hasn't come back in 6 months.
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My kidney function is good.
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My liver cancer is at a stage where it can be treated and the largest tumor is 8 cm or smaller.
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I have not been treated or my cancer returned with a new tumor after initial treatment.
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I am mentally capable and willing to sign the consent form.
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My platelet count is above 50,000 without transfusions or growth factors.
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My blood, liver, and kidney tests are within normal ranges.
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My liver function is slightly impaired.
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My doctor expects me to live more than 3 months without treatment.
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My tumors can be measured using a CT scan or MRI.
DOORwaY90 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Response (DoR)
Overall Response Rate (ORR)
Secondary outcome measures
Grade ≥ 3 toxicity (CTCAE v5.0)
Incidence of liver resection
Incidence of liver transplant
+2 moreDOORwaY90 Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-label Single ArmExperimental Treatment1 Intervention
Open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.
Find a Location
Who is running the clinical trial?
Sirtex MedicalLead Sponsor
28 Previous Clinical Trials
4,170 Total Patients Enrolled
1 Trials studying Liver Cancer
36 Patients Enrolled for Liver Cancer
Bright Research PartnersIndustry Sponsor
13 Previous Clinical Trials
1,654 Total Patients Enrolled
Armeen Mahvash, M.D.Principal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have issues with my bile ducts or have had procedures on them.I am 18 years old or older.My liver cancer diagnosis was confirmed by specific imaging or tissue analysis.You have experienced serious allergic reactions or have had bad reactions to contrast agents, narcotics, or sedatives in the past.I am currently being treated for another type of cancer.I have no detectable abnormal flow of a tracer outside my liver after certain procedures.My treatment plan includes a high dose of radiation to the lungs.I am scheduled for ongoing cancer treatment during the study.I need oxygen therapy regularly due to a lung condition.I have had signs of high blood pressure in the liver veins or bleeding from these veins in the last 6 months.I had liver surgery with clear margins, no tiny vessel invasion, and no new or returning cancer for 6 months.I am not planning any liver cancer treatments other than the study treatment.I had a small tumor treated without surgery and it hasn't come back in 6 months.My kidney function is good.I have a blood clot in the vein to my liver.I do not have an active infection, except for treated hepatitis C or controlled hepatitis B.My liver cancer is at a stage where it can be treated and the largest tumor is 8 cm or smaller.I am not pregnant, breastfeeding, and if premenopausal, I am willing to use contraception for 1 year. If male, I agree to use contraception for 30 days post-procedure.I have not been treated or my cancer returned with a new tumor after initial treatment.I have received treatments like immunotherapy or radiotherapy for liver cancer before.I am mentally capable and willing to sign the consent form.My platelet count is above 50,000 without transfusions or growth factors.My blood, liver, and kidney tests are within normal ranges.My liver function is slightly impaired.My doctor expects me to live more than 3 months without treatment.I cannot undergo angiography or selective visceral catheterization due to health risks.Less than a third of my liver is free of disease and won't be treated with SIR-Spheres.My cancer has spread outside of my liver.I have a history of blood clotting disorders.My cancer is considered suitable for surgical removal or ablation.My tumors can be measured using a CT scan or MRI.I have had liver surgery or a transplant, but still meet other specific criteria.There are blood vessels connected to the tumor from outside the liver.I have blood vessels in my liver that are abnormally connected, but it's okay if it was caused by a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Open-label Single Arm
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.
What is the main objective of this clinical research endeavor?
"According to the data provided by Bright Research Partners, the primary measurement of success for this 12 month trial is Overall Response Rate (ORR). Alongside this key metric, there are several secondary outcomes that will be monitored including EuroQol 5 Dimension 5 Level Questionnaire scores, Common Terminology Criteria for Adverse Events grade 3 toxicity ratings and incidence of liver resection procedures."
Answered by AI
What is the upper-bound of participants involved in this experiment?
"Affirmative, the information on clinicialtrials.gov confirms that this medical trial is seeking volunteers; it was initially published in May 2021 and revised as recently as September 2022. The study requires 100 individuals to be recruited from 16 different centres."
Answered by AI
What is the current geographic scope of this trial?
"This medical study is taking place across 16 different clinics, three of which are located in Mission Hills, Chicago and Houston. To reduce travel needs during the trial, interested parties should select a clinic as close to them as possible."
Answered by AI
Are there any remaining slots open for participants in this trial?
"Clinicaltrials.gov states that this experiment is currently in need of subjects, with the initial posting occurring on May 28th 2021 and the most recent update taking place September 15th 2022."
Answered by AI
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