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Liver CancerPhase 2/3SATURNENCT01164202

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

A Phase 2/3 study testing sunitinib malate and transarterial chemoembolization in people with Liver Cancer, run by Federation Francophone de Cancerologie Digestive at 31 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Liver Cancer
What is being tested?
sunitinib malate and transarterial chemoembolization
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
31 sitesFrance
Study dates
Jul 2010to Jul 2017
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • CHU Nord

    Amiens

  • CHR

    Annecy

  • Institut Sainte Catherine

    Avignon

  • CHU J Minjoz

    Besançon

  • CH

    Béziers

  • Institut Bergonié

    Bordeaux

  • CHU Côte de Nacre

    Caen

  • CHU

    Clermont-Ferrand

  • Clinique des Cèdres

    Cornebarrieu

  • CHU Bocage

    Dijon

  • CH

    Guilherand-Granges

  • Hôpital Claude Huriez

    Lille, 59037

  • Hopital Dupuytren

    Limoges

  • CHBS

    Lorient

  • Hôpital Privé Jean Mermoz

    Lyon

  • CH Ambroise Paré

    Marseille

  • CH Conception

    Marseille

  • CHU La Timone

    Marseille

  • Hôpital Saint Joseph

    Marseille

  • CHRU Saint Eloi

    Montpellier

  • CHU -Hôpital de l'Archet II

    Nice

  • CHR

    Orléans

  • Hopital Tenon

    Paris, 75970

  • Groupe Hospitalier Paris St Joseph

    Paris

  • Hôpital Européen Georges Pompidou

    Paris

  • CHU Jean Bernard

    Poitiers

  • CHU Robert Debré

    Reims

  • CAC

    Rennes

  • CHU

    Rouen

  • CHU

    Tours

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

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)

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.

Read the 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.

Conditions
Liver Cancer
Being tested
sunitinib malate, Placebo, transarterial chemoembolization
Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sunitinib malateDrug

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

  • PlaceboDrug

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

  • transarterial chemoembolizationProcedure or surgery

    Chimioembolisation

Study groups in NCT01164202
Study groupRoleWhat they receive
PlaceboPlacebo comparatorplacebo 3cps/days 4 weeks over 6 during 1 year
Receives: Drug: Placebo; Procedure: transarterial chemoembolization
SunitinibExperimentalsunitinib (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
Receives: Drug: sunitinib malate; Procedure: transarterial chemoembolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 7 days following each TACE, up to 5 months of treatment

Secondary outcomes (2)

  1. 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.

    Measured: From randomization until death or last news for alive patients, up to 3 years

  2. 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.

    Measured: From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01164202
Sponsor's protocol ID
PRODIGE 16
Other IDs
FFCD-PRODIGE-16, FFCD-0905, EUDRACT-2009-017064-16, EU-21050
Acronym
SATURNE
Status last verified
Mar 2022
First submitted
15 Jul 2010
Last updated
18 Mar 2022
Data monitoring committee
No

Publications

  • 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.

    PubMed 32576496

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing sunitinib malate and transarterial chemoembolization in people with Liver Cancer, run by Federation Francophone de Cancerologie Digestive at 31 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Yes. Results are posted in the registry (first posted 18 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure (time frame: Up to 7 days following each TACE, up to 5 months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01164202, which also lists 1 linked publication.

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 18 Mar 2022.

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