Status:
COMPLETED
Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oi...
Detailed Description
OBJECTIVES: Primary * Determine whether treatment with adjuvant intra-arterial iodine I 131 ethiodized oil reduces the percentage of tumor recurrence in patients with curatively treated hepatocellul...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of hepatocellular carcinoma (HCC)
- Alpha-fetoprotein \< 20 ng/mL
- Must have undergone curative treatment for HCC within the past 8-20 weeks, including 1 of the following:
- Curative resection
- Alcohol ablation, radiofrequency ablation, or cryotherapy (for 1 or 2 nodules \< 5 cm in diameter)
- No ascites
- No other intrahepatic involvement or nodule progression as assessed by ultrasound
- No extrahepatic metastases
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 50,000/mm³
- Bilirubin ≤ 51 μmol/L
- Creatinine ≤ 120 μmol/L
- Not pregnant or nursing
- Negative pregnancy test
- Child-Pugh score \< 8 (class B)
- No decompensated cirrhosis
- No encephalopathy
- No uncontrolled bleeding
- No portal thrombosis, right- or left-branch thrombosis, extrahepatic thrombosis, or portal reflux by doppler or CT scan
- No unstable medical or surgical disease
- No contraindication to vascular arteriography
- No history of complications after injection of iodine contrast agents
- Not incarcerated
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- No prior hormonal treatment, including tamoxifen and somatostatin analogs
- No prior systemic chemotherapy
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00870558
Start Date
June 1 2005
Last Update
August 16 2011
Active Locations (1)
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1
Hopital Edouard Herriot - Lyon
Lyon, France, 69437