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

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Civil Hospices of Lyon

Status and phase

Completed
Phase 3

Conditions

Liver Cancer

Treatments

Radiation: iodine I 131 ethiodized oil
Drug: 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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