Track topics on Twitter Track topics that are important to you
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping anticancer drugs near the tumor. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether chemoembolization is more effective with or without sunitinib malate in treating patients with liver cancer.
PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization of the liver and to see how well in works when given together with or without sunitinib malate in treating patients with liver cancer.
- To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in patients with hepatocellular carcinoma treated with transarterial chemoembolization in combination with sunitinib malate versus transarterial chemoembolization alone.
- To evaluate the overall survival of these patients.
- To evaluate the tumor stabilization rate in these patients.
- To evaluate the safety of this regimen in these patients.
- To evaluate the disease-free survival of these patients.
- To evaluate the relapse-free survival of these patients.
- To evaluate the quality of life of these patients.
- To evaluate the overall survival rate at 2 years in these patients.
OUTLINE: This is a multicenter study.
Pilot phase: Patients receive oral sunitinib malate once daily on days 1-28. Beginning 7-10 days later, patients undergo 1-3 courses of transarterial chemoembolization (TACE). Treatment repeats every 6 weeks for 1 year.
Patients are stratified according to main tumor diameter (< 5 cm vs ≥ 5 cm), nodular involvement (uninodular vs multinodular), and center. Patients are then randomized to 1 of 2 treatment arms.
- Arm I: Patients receive sunitinib malate and TACE as in the pilot phase.
- Arm II: Patients receive oral placebo once daily on days 1-28 and TACE as in the pilot phase.
Quality of life is assessed periodically.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment
sunitinib malate, quality-of-life assessment, transarterial chemoembolization
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:12:10-0400
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Chemoembolization kills tumor cells ...
Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization
This randomized phase III trial studies how well transarterial chemoembolization (TACE) works compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation ther...
The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different protocols of transarterial chemoembolization (TACE) in patients with hepatocellu...
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination....
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoem...
Loco-regional complications of transarterial chemoembolization (TACE) may adversely affect technical aspects of the liver transplantation (LT). This study reviewed the impact of those complications on...
We aimed to compare the clinical effectiveness of combination therapy of transarterial chemoembolization (TACE) and microwave ablation (MWA) with TACE monotherapy in BCLC stage B HCC patients with tum...
The purpose of the study was to evaluate safety, time to recurrence, and overall survival (OS) in patients with liver metastases (LM), treated with transarterial chemoembolization (TACE) followed by a...
Although resilience has many positive effects on cancer patients, little is known about the level of resilience and its predictors in Chinese liver cancer patients undergoing transarterial chemoemboli...
Combined hepatocellular-cholangiocarcinoma (cHCC-CC) can present as a hypervascular or peripherally enhancing tumor in dynamic imaging. We evaluated the effect of transarterial chemoembolization (TACE...
An enzyme that catalyzes the conversion of (S)-malate and NAD+ to oxaloacetate and NADH. EC 184.108.40.206.
A light-activated enzyme that catalyzes the oxidation of (S)-malate to OXALOACETATE. It is involved in PYRUVATE metabolism and CARBON fixation.
A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...