Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed… (NCT00532740) | Clinical Trial Compass
CompletedNot Applicable
Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
United States2,000 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 metastatic liver cancer that cannot be removed by surgery.
Who can participate
Age range18 Years
SexALL
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 metastatic 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
* FDA approval to receive compassionate use of yttrium Y 90 glass microspheres
* No significant extrahepatic disease representing an imminent life-threatening outcome
* No evidence of potential delivery of \> 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either of the following:
* First administration of yttrium Y 90 glass microspheres (TheraSphere ®)
* Cumulative delivery of radiotherapy to the lungs over multiple treatments
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* Absolute granulocyte count ≥ 1,500/µL
* Platelet count ≥ 25,000/μL
* 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)
* No contraindication to angiography or selective visceral catheterization, including any of the following:
* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques
…