Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	HCL-2004.348/3 HCL 2004.348/3, INCA-RECF0436, HCL-LIPIODOL, NCT00870558

Objectives

Primary

1. 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

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

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• Recovered from all prior therapy
• No prior hormonal treatment, including tamoxifen and somatostatin analogs
• No prior systemic chemotherapy

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

Expected Enrollment

Outcomes

Tumor recurrence at 2 years

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.

Trial Contact Information

Trial Lead Organizations

Hospices Civils de Lyon

Jerome Dumortier, MD, Study coordinator		Ph: 33-4-7211-7401

Registry Information
Official Title		Adjuvant treatment by intra-arterial injection of lipiodol-labeled iodine-131 in preventing recurrence of hepatocellular carcinoma after curative treatment
Trial Start Date		2005-06-02
Trial Completion Date		2009-02-01 (estimated)
Registered in ClinicalTrials.gov		NCT00870558
Date Submitted to PDQ		2008-11-12
Information Last Verified		2009-04-03