NCT00870558

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

August 16, 2011

Status Verified

April 1, 2009

Enrollment Period

5.9 years

First QC Date

March 26, 2009

Last Update Submit

August 13, 2011

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinomaadvanced adult primary liver cancerlocalized resectable adult primary liver cancerlocalized unresectable adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor recurrence at 2 years

Study Arms (2)

Arm I

EXPERIMENTAL

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

Radiation: iodine I 131 ethiodized oil

Arm II

PLACEBO COMPARATOR

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

Drug: ethiodized oil

Interventions

ethiodized oilDRUG

Given as an intra-arterial infusion

Arm II
iodine I 131 ethiodized oilRADIATION

Given as an intra-arterial infusion

Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Ethiodized Oil

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Iodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Jerome Dumortier, MD

    Hopital Edouard Herriot - Lyon

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

June 1, 2005

Primary Completion

May 1, 2011

Last Updated

August 16, 2011

Record last verified: 2009-04

Locations

FR(1)