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Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer (SATURNE)

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
sunitinib malate
Placebo
transarterial chemoembolization
Sponsored by
Federation Francophone de Cancerologie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed hepatocellular carcinoma or liver tumor responding to the Barcelona criteria
  • Child-Pugh score of 5-6 (Class A)
  • Tumor suitable for transarterial chemoembolization (one or more planned courses allowed)
  • Tumor not suitable for surgical resection
  • No extrahepatic metastases, including cerebral metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 10 g/dL
  • PT ≥ 50%
  • Creatinine ≤ 120 μmol/L
  • Bilirubin normal
  • ALT/AST ≤ 3.5 times upper limit of normal (ULN)
  • Alkaline phosphatases ≤ 4 times ULN
  • Fibrinogen ≥ 1.5 g/L
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No portal vein thrombosis
  • Able to comply with scheduled follow-up and management of toxicity
  • No uncontrolled hypertension or requiring ≥ 2 classes of antihypertensive drugs
  • No concomitant disease or uncontrolled severe disease
  • No contraindications to the vascular occlusion procedure
  • No prior or concurrent malignancy within the past 5 years, except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • No psychiatric disability or social, family, or geographic reason for which the patient may not be followed regularly

PRIOR CONCURRENT THERAPY:

  • At least 7 days since prior CYP3A4 inhibitors or inducers
  • At least 3 months since prior radiofrequency ablation
  • No prior chemotherapy
  • No prior sunitinib, sorafenib, or any other inhibitors of angiogenesis
  • No concurrent participation in another trial

Sites / Locations

  • CHU Nord
  • CHR
  • Institut Sainte Catherine
  • CHU J Minjoz
  • Institut Bergonié
  • CH
  • CHU Côte de Nacre
  • CHU
  • Clinique des Cèdres
  • CHU Bocage
  • CH
  • Hôpital Claude Huriez
  • Hopital Dupuytren
  • CHBS
  • Hôpital Privé Jean Mermoz
  • CH Ambroise Paré
  • CH Conception
  • CHU La Timone
  • Hôpital Saint Joseph
  • CHRU Saint Eloi
  • CHU -Hôpital de l'Archet II
  • CHR
  • Hopital Tenon
  • Groupe Hospitalier Paris St Joseph
  • Hôpital Européen Georges Pompidou
  • CHU Jean Bernard
  • CHU Robert Debré
  • CAC
  • CHU
  • CHU
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Sunitinib

Arm Description

placebo 3cps/days 4 weeks over 6 during 1 year

sunitinib (SUTENT®) 37,5 mg/d (3 cps of 12,5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year

Outcomes

Primary Outcome Measures

Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure
The number of patients with at least one bleed and/or liver failure by treatment group

Secondary Outcome Measures

Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death (from any cause). Patients lost to follow-up or alive at the time of analysis are censored at the last news date or the point date. This time is used to calculate the median follow-up time.
Disease-free Survival
Disease-free survival is defined as the time interval between randomization and local or distant relapse or second cancer or death (all causes). Alive patients are censored at the last follow-up.

Full Information

First Posted
July 15, 2010
Last Updated
March 17, 2022
Sponsor
Federation Francophone de Cancerologie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT01164202
Brief Title
Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
Acronym
SATURNE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 3cps/days 4 weeks over 6 during 1 year
Arm Title
Sunitinib
Arm Type
Experimental
Arm Description
sunitinib (SUTENT®) 37,5 mg/d (3 cps of 12,5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Intervention Description
placebo 3cps/days 4 weeks over 6 during 1 year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo 3cps/days 4 weeks over 6 during 1 year
Intervention Type
Procedure
Intervention Name(s)
transarterial chemoembolization
Intervention Description
Chimioembolisation
Primary Outcome Measure Information:
Title
Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure
Description
The number of patients with at least one bleed and/or liver failure by treatment group
Time Frame
Up to 7 days following each TACE, up to 5 months of treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is defined as the time from the date of randomization to the date of death (from any cause). Patients lost to follow-up or alive at the time of analysis are censored at the last news date or the point date. This time is used to calculate the median follow-up time.
Time Frame
From randomization until death or last news for alive patients, up to 3 years
Title
Disease-free Survival
Description
Disease-free survival is defined as the time interval between randomization and local or distant relapse or second cancer or death (all causes). Alive patients are censored at the last follow-up.
Time Frame
From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed hepatocellular carcinoma or liver tumor responding to the Barcelona criteria Child-Pugh score of 5-6 (Class A) Tumor suitable for transarterial chemoembolization (one or more planned courses allowed) Tumor not suitable for surgical resection No extrahepatic metastases, including cerebral metastases PATIENT CHARACTERISTICS: ECOG performance status 0-2 Absolute neutrophil count ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L Hemoglobin ≥ 10 g/dL PT ≥ 50% Creatinine ≤ 120 μmol/L Bilirubin normal ALT/AST ≤ 3.5 times upper limit of normal (ULN) Alkaline phosphatases ≤ 4 times ULN Fibrinogen ≥ 1.5 g/L Not pregnant or nursing Fertile patients must use effective contraception No portal vein thrombosis Able to comply with scheduled follow-up and management of toxicity No uncontrolled hypertension or requiring ≥ 2 classes of antihypertensive drugs No concomitant disease or uncontrolled severe disease No contraindications to the vascular occlusion procedure No prior or concurrent malignancy within the past 5 years, except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the skin No psychiatric disability or social, family, or geographic reason for which the patient may not be followed regularly PRIOR CONCURRENT THERAPY: At least 7 days since prior CYP3A4 inhibitors or inducers At least 3 months since prior radiofrequency ablation No prior chemotherapy No prior sunitinib, sorafenib, or any other inhibitors of angiogenesis No concurrent participation in another trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Hebbar, MD
Organizational Affiliation
Centre Hospital Universitaire Hop Huriez
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nord
City
Amiens
Country
France
Facility Name
CHR
City
Annecy
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
Country
France
Facility Name
CHU J Minjoz
City
Besancon
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Facility Name
CH
City
Béziers
Country
France
Facility Name
CHU Côte de Nacre
City
Caen
Country
France
Facility Name
CHU
City
Clermont Ferrand
Country
France
Facility Name
Clinique des Cèdres
City
Cornebarrieu
Country
France
Facility Name
CHU Bocage
City
Dijon
Country
France
Facility Name
CH
City
Guilherand Granges
Country
France
Facility Name
Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Dupuytren
City
Limoges
Country
France
Facility Name
CHBS
City
Lorient
Country
France
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
Country
France
Facility Name
CH Ambroise Paré
City
Marseille
Country
France
Facility Name
CH Conception
City
Marseille
Country
France
Facility Name
CHU La Timone
City
Marseille
Country
France
Facility Name
Hôpital Saint Joseph
City
Marseille
Country
France
Facility Name
CHRU Saint Eloi
City
Montpellier
Country
France
Facility Name
CHU -Hôpital de l'Archet II
City
Nice
Country
France
Facility Name
CHR
City
Orléans
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Groupe Hospitalier Paris St Joseph
City
Paris
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Facility Name
CHU Jean Bernard
City
Poitiers
Country
France
Facility Name
CHU Robert Debré
City
Reims
Country
France
Facility Name
CAC
City
Rennes
Country
France
Facility Name
CHU
City
Rouen
Country
France
Facility Name
CHU
City
Tours
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32576496
Citation
Turpin A, de Baere T, Heurgue A, Le Malicot K, Ollivier-Hourmand I, Lecomte T, Perrier H, Vergniol J, Sefrioui D, Rinaldi Y, Edeline J, Jouve JL, Silvain C, Becouarn Y, Dauvois B, Baconnier M, Debette-Gratien M, Deplanque G, Dharancy S, Lepage C, Hebbar M; PRODIGE 16 investigators Collaborators. Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study. Clin Res Hepatol Gastroenterol. 2021 Mar;45(2):101464. doi: 10.1016/j.clinre.2020.05.012. Epub 2020 Jun 21.
Results Reference
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Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer

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