Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver (NCT00003907) | Clinical Trial Compass
CompletedPhase 2
Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
United States50 participantsStarted 1999-12-15
Plain-language summary
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.
PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.
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.
Inclusion Criteria:
* Biopsy-proven intrahepatic hepatocellular carcinoma or neuroendocrine tumor.
* Unresectable.
* Bidimensionally measurable disease by Computed Tomography (CT), Magnetic resonance imaging (MRI), or UltraSound Scanning (US) within 6 weeks of registration.
* Evidence of patent portal vasculature by Doppler US, MRI, or angiography.
* Serum total bilirubin \< 2.0 mg/dl and serum creatinine \< 2.0 mg/dl within 4 weeks of registration.
* Absolute neutrophil count (ANC) \> 2000/µl and platelets \> 50,000/µl within 4 weeks of registration.
* Expected survival of at least 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Age \>= 18 years.
Exclusion Criteria:
* Evidence of extrahepatic disease that is likely to be life-threatening within 3 months, such as brain or symptomatic lung metastases.
* Previous intra-arterial or intra-hepatic chemotherapy or prior systemic chemotherapy within 4 weeks.
* Concurrent malignancy.
* Pregnant or breast-feeding women.
* History of life-threatening contrast allergy.
What they're measuring
1
Time to Progression
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 year.