Liver CancerPhase 3NCT00870558
Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer
A Phase 3 study testing ethiodized oil and iodine I 131 ethiodized oil in people with Liver Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- ethiodized oil and iodine I 131 ethiodized oil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment
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.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- ethiodized oil, iodine I 131 ethiodized oil
- Keywords
- adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethiodized oilDrug
Given as an intra-arterial infusion
iodine I 131 ethiodized oilRadiation
Given as an intra-arterial infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil. Receives: Radiation: iodine I 131 ethiodized oil |
| Arm II | Placebo comparator | Patients receive an intra-arterial infusion of unlabeled ethiodized oil. Receives: Drug: ethiodized oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor recurrence at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startJun 2005
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Jerome Dumortier, MD, Hopital Edouard Herriot - Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870558
- Sponsor's protocol ID
- CDR0000626727
- Other IDs
- HCL-2004-348-3, INCA-RECF0436, HCL-LIPIODOL
- Status last verified
- Apr 2009
- First submitted
- 26 Mar 2009
- Last updated
- 16 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment
- ClinicalTrials.gov ID
- NCT00870558
- Acronym / sponsor ID
- CDR0000626727
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- May 2011 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: iodine I 131 ethiodized oilPatients receive an intra-arterial infusion of iodine I 131 ethiodized oil. |
| Arm II | Placebo comparator | Drug: ethiodized oilPatients receive an intra-arterial infusion of unlabeled ethiodized oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ethiodized oilGiven as an intra-arterial infusion | Drug | Arm II |
| iodine I 131 ethiodized oilGiven as an intra-arterial infusion | Radiation | Arm I |
Primary outcome
Tumor recurrence at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome Dumortier, MD
Hopital Edouard Herriot - Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ethiodized oil and iodine I 131 ethiodized oil in people with Liver Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor recurrence at 2 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.