Clinical trial NCT00870558: Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer
Official title: Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Cancer
Keywords: adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized resectable adult primary liver cancer
localized unresectable adult primary liver cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Tumor recurrence at 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot - Lyon
Study officials:
affiliation: Hopital Edouard Herriot - Lyon
name: Jerome Dumortier, MD
References: