Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.

PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Cadexomer iodine; Ethiodized Oil; Iodine

Criteria

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