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 range18 Years
SexALL
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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…
What they're measuring
1
Patient Completion
Timeframe: Through study completion, up to 24 months or when patient discontinues treatment for whatever reason.