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

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Liver Cancer

Treatments: Drug: ethiodized oil; Radiation: iodine I 131 ethiodized oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00870558

HCL-LIPIODOL

CDR0000626727

HCL-2004-348-3

INCA-RECF0436

Details and patient eligibility

About

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.

Full 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 hepatocellular carcinoma.

Secondary

• Evaluate the overall and recurrence-free survival of these patients.
• Evaluate the deterioration of liver function in these patients.
• Evaluate the toxicity of intra-arterial iodine I 131 ethiodized oil in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.
• Arm II: Patients receive an intra-arterial infusion of unlabeled ethiodized oil.

After completion of study treatment, patients are followed periodically for 5 years.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

120 participants in 2 patient groups, including a placebo group

Arm I

Experimental group

Description:

Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.

Treatment:

Radiation: iodine I 131 ethiodized oil

Arm II

Placebo Comparator group

Description:

Patients receive an intra-arterial infusion of unlabeled ethiodized oil.

Treatment:

Drug: ethiodized oil