Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery (NCT00530010) | Clinical Trial Compass
CompletedNot Applicable
Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
United States500 participantsStarted 2004-12
Plain-language summary
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.
PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Confirmed diagnosis of intrahepatic carcinoma
* Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP
* Unresectable disease
* No portal hypertension with portal venous shunt away from the liver
* No significant extrahepatic disease representing an imminent life-threatening outcome
* No evidence of potential delivery of \> 16.5 mCi (30 Gy absorbed dose) radiation to the lungs on either of the following:
* First yttrium Y 90 glass microspheres (TheraSphere®) administration
* Cumulative delivery of radiation to the lungs over multiple treatments
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-2
* Absolute granulocyte count ≥ 1,500/μL
* Platelet count \> 25,000/μL
* Serum creatinine \< 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)
* Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin and the tumor may be isolated from a vascular standpoint, treatment may proceed)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
Exclusion criteria:
* Any of the following contraindications to angiography and selective visceral catheterization:
* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Completion
Timeframe: Through study completion, up to 24 months or when patient discontinues treatment for whatever reason.