Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT01164202
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2010-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Phase II/III Study Comparing the Use of Chemoembolization Combined With Sunitinib Against Chemoembolization Combined With a Placebo in Patients With Hepatocellular Carcinoma (SATURNE)
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SATURNE
Brief Summary:
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.
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.
Detailed Description:
OBJECTIVES:
Primary
* To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in patients with unresectable hepatocellular carcinoma treated with transarterial chemoembolization in combination with sunitinib malate versus transarterial chemoembolization alone.
* To evaluate the overall survival of these patients.
Secondary
* 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 of these patients.
OUTLINE: This is a multicenter study.
Pilot: 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.
Randomization: Patients are stratified according to main tumor diameter (\< 5 cm vs ≥ 5 cm), nodular involvement (uninodular vs multinodular), and center. Patients are 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.
Primary
* To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in patients with unresectable hepatocellular carcinoma treated with transarterial chemoembolization in combination with sunitinib malate versus transarterial chemoembolization alone.
* To evaluate the overall survival of these patients.
Secondary
* 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 of these patients.
OUTLINE: This is a multicenter study.
Pilot: 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.
Randomization: Patients are stratified according to main tumor diameter (\< 5 cm vs ≥ 5 cm), nodular involvement (uninodular vs multinodular), and center. Patients are 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: