Liver CancerPhase 3NCT00027768
Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
A Phase 3 study testing adjuvant therapy and iodine I 131 ethiodized oil in people with Liver Cancer, run by National Medical Research Council (NMRC), Singapore at 3 sites in Singapore.
Trial summary
RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- adjuvant therapy and iodine I 131 ethiodized oil
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 3 sitesSingapore
- Study dates
- Jun 2001to not given
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary hepatocellular carcinoma (HCC)
- Completely resected disease with clear margins
- No residual disease by postoperative CT scan
- No metastatic disease
PATIENT CHARACTERISTICS:
Age:
- 17 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 1,500/mm^3
- Platelet count greater than 50,000/mm^3
Hepatic:
- Bilirubin less than 2.92 mg/dL
- PT less than 4 seconds over control
Renal:
- Creatinine less than 2.26 mg/dL
Other:
- No contraindication to contrast or radioactive iodine
- No uncontrolled thyrotoxicosis
- No other prior or concurrent malignancy
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- No other prior treatment for HCC
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
National Cancer Centre - Singapore
Singapore, 169610
Tan Tock Seng Hospital
Singapore, 308433
Changi General Hospital
Singapore, 529889
About this study
Official title: Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery.
PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.
Read the detailed description
OBJECTIVES:
- Compare the effect of adjuvant hepatic intra-arterial iodine I 131 lipiodol vs observation in terms of rate of recurrence and overall survival of patients with curatively resected hepatocellular carcinoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Within 4-6 weeks after prior resection, patients receive adjuvant hepatic intra-arterial iodine I 131 lipiodol once.
- Arm II: After prior resection, patients undergo observation. Patients are followed monthly for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.
- Conditions
- Liver Cancer
- Being tested
- adjuvant therapy, iodine I 131 ethiodized oil
- Keywords
- localized resectable adult primary liver cancer, adult primary hepatocellular carcinoma
- 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.
adjuvant therapyProcedure or surgery
iodine I 131 ethiodized oilRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Secondary outcomes (1)
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2001
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.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Council (NMRC), Singapore
- Sponsor type
- Other government
- Investigators
- London L. Ooi Peng Jin, MD, Study chair, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027768
- Sponsor's protocol ID
- CDR0000069066
- Other IDs
- NMRC-AHCC03, EU-20128
- Status last verified
- Jun 2007
- First submitted
- 7 Dec 2001
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00027768
- Acronym / sponsor ID
- CDR0000069066
- Conditions
- Liver Cancer
- Keywords
- localized resectable adult primary liver cancer, adult primary hepatocellular carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Medical Research Council (NMRC), SingaporeOther government
- Study start
- Jun 2001
- First posted
- 27 Jan 2003 (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: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery.
PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.
Detailed description
OBJECTIVES:
- Compare the effect of adjuvant hepatic intra-arterial iodine I 131 lipiodol vs observation in terms of rate of recurrence and overall survival of patients with curatively resected hepatocellular carcinoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Within 4-6 weeks after prior resection, patients receive adjuvant hepatic intra-arterial iodine I 131 lipiodol once.
- Arm II: After prior resection, patients undergo observation. Patients are followed monthly for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| adjuvant therapy | Procedure or surgery | – |
| iodine I 131 ethiodized oil | Radiation | – |
Primary outcome
Recurrence-free survival
1 secondary outcome
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
London L. Ooi Peng Jin, MD study chair
National Cancer Centre, Singapore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adjuvant therapy and iodine I 131 ethiodized oil in people with Liver Cancer, run by National Medical Research Council (NMRC), Singapore at 3 sites in Singapore.
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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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. 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?
Results are not available in the source record.
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?
Recurrence-free survival. 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 20 Sep 2013.