Localized Resectable Adult Primary Liver CancerPhase 3NCT00238160
Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer
A Phase 3 study testing cisplatin, fluorouracil and adjuvant therapy in people with Localized Resectable Adult Primary Liver Cancer and Stage III Childhood Liver Cancer, run by Kyoto University at 4 sites in Japan.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Localized Resectable Adult Primary Liver Cancer, Stage III Childhood Liver Cancer
- What is being tested?
- cisplatin, fluorouracil and adjuvant therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 4 sitesJapan
- Study dates
- Start not givento 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed hepatocellular carcinoma (HCC) with portal vein tumor thrombus
- Tumor thrombus in the main trunk or first branch of the portal vein
- No apparent distant metastases on chest CT scan and bone scintigraphy within the past 6 weeks
- No pleural effusion or ascites
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count > 1,000/mm^3
- Platelet count > 50,000/mm^3
- Hemoglobin > 8 g/dL
Hepatic
- Bilirubin < 2 times upper limit of normal (ULN)
- ALT and AST < 4 times ULN
Renal
- Creatinine normal
Cardiovascular
- No severe heart disease
- No cardiac effusion
Other
- No other malignant disease
- No high risk for esophageal varices rupture
- No allergy to fluorouracil or cisplatin
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior hepatic arterial chemotherapy
- No prior systemic chemotherapy for HCC
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Kyoto City Hospital
Kyoto, 604-8845
Kyoto University Hospital
Kyoto, 606-8501
Kyoto-Katsura Hospital
Kyoto, 615-8256
About this study
Official title: Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether surgery and hepatic arterial chemotherapy are more effective than surgery alone in treating patients with liver cancer that has spread to the portal vein.
PURPOSE: This randomized phase III trial is studying surgery and hepatic arterial chemotherapy to see how well they work compared to surgery alone in treating patients with liver cancer that has spread to the portal vein.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of surgical resection with vs without postoperative hepatic arterial chemotherapy in patients with hepatocellular carcinoma and portal vein tumor thrombus.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to grade of portal invasion and Child-Pugh classification. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo macroscopic curative resection. Within 28 days after surgery, patients without post-surgery complications undergo hepatic arterial infusion comprising fluorouracil and cisplatin on days 1-5, 8-12, and 15-19. Treatment continues for 6 months.
- Arm II: Patients undergo macroscopic curative resection.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
- Being tested
- cisplatin, fluorouracil, adjuvant therapy, chemotherapy, conventional surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
adjuvant therapyProcedure or surgery
chemotherapyProcedure or surgery
conventional surgeryProcedure or surgery
hepatic arterial infusionProcedure or surgery
surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Resectable Adult Primary 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Investigators
- Iwao Ikai, MD, Study chair, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238160
- Sponsor's protocol ID
- KYUH-UHA-HCC02-01
- Other IDs
- CDR0000363800
- Status last verified
- Jul 2006
- First submitted
- 12 Oct 2005
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus
- ClinicalTrials.gov ID
- NCT00238160
- Acronym / sponsor ID
- KYUH-UHA-HCC02-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- First posted
- 13 Oct 2005 (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: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether surgery and hepatic arterial chemotherapy are more effective than surgery alone in treating patients with liver cancer that has spread to the portal vein.
PURPOSE: This randomized phase III trial is studying surgery and hepatic arterial chemotherapy to see how well they work compared to surgery alone in treating patients with liver cancer that has spread to the portal vein.
Detailed description
OBJECTIVES:
- Compare the efficacy of surgical resection with vs without postoperative hepatic arterial chemotherapy in patients with hepatocellular carcinoma and portal vein tumor thrombus.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to grade of portal invasion and Child-Pugh classification. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo macroscopic curative resection. Within 28 days after surgery, patients without post-surgery complications undergo hepatic arterial infusion comprising fluorouracil and cisplatin on days 1-5, 8-12, and 15-19. Treatment continues for 6 months.
- Arm II: Patients undergo macroscopic curative resection.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- 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 |
|---|---|---|
| cisplatin | Drug | – |
| fluorouracil | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| chemotherapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| hepatic arterial infusion | Procedure or surgery | – |
| surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 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.
Iwao Ikai, MD study chair
Kyoto University Hospital
4 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 cisplatin, fluorouracil and adjuvant therapy in people with Localized Resectable Adult Primary Liver Cancer and Stage III Childhood Liver Cancer, run by Kyoto University at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 30 May 2013.