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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ethiodized oil
iodine I 131 ethiodized oil
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Edouard Herriot - Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

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

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

Outcomes

Primary Outcome Measures

Tumor recurrence at 2 years

Secondary Outcome Measures

Full Information

First Posted
March 26, 2009
Last Updated
August 13, 2011
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00870558
Brief Title
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

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive an intra-arterial infusion of unlabeled ethiodized oil.
Intervention Type
Drug
Intervention Name(s)
ethiodized oil
Intervention Description
Given as an intra-arterial infusion
Intervention Type
Radiation
Intervention Name(s)
iodine I 131 ethiodized oil
Intervention Description
Given as an intra-arterial infusion
Primary Outcome Measure Information:
Title
Tumor recurrence at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome Dumortier, MD
Organizational Affiliation
Hopital Edouard Herriot - Lyon
Facility Information:
Facility Name
Hopital Edouard Herriot - Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France

12. IPD Sharing Statement

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

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