Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer (NCT00238160) | Clinical Trial Compass
WithdrawnPhase 3
Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer
Japan0
Plain-language 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. 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.