NCT00843934

Brief Summary

The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 19, 2012

Status Verified

October 1, 2012

Enrollment Period

3.8 years

First QC Date

February 12, 2009

Last Update Submit

October 17, 2012

Conditions

Carcinoma, Hepatocellular

Keywords

Carcinoma, HepatocellularTrans arterial chemoembolizationEpirubicinCisplatin

Outcome Measures

Primary Outcomes (1)

  • response rate

    6 months

Study Arms (1)

anti-cancer agent

EXPERIMENTAL
Drug: epirubicinDrug: Cisplatin

Interventions

epirubicinDRUG

Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively.

Also known as: epi-adriamycin
anti-cancer agent
CisplatinDRUG

Arm C: Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively.

Also known as: CDDP
anti-cancer agent

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has measurable lesions.
  • Subject must to be the first experience of TACE.
  • Subject has no extra-hepatic tumor and no obstruction of main portal vein.
  • Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy).
  • ECOG performance status 0-2
  • Child-pugh Class A or B
  • Subject must have adequate functions of bonemarrow, renal, circulatory organs and appropriate examination results as below:
  • Serum Total Bilirubin 2.0mg/mL
  • WBC 3000/mm3
  • PLT 50000/mm3
  • Hb 9.0g/dL
  • Creatinine ; upper normal limit (UNL)
  • BUN 25mg/dL
  • Written informed consent

You may not qualify if:

  • Subject has extra hepatic metastasis.
  • Tumor thrombosis exists at main portal vein.
  • Remarkable artery-portal vein shunt or veno-arterial shunt.
  • Uncontrollable ascites or pleural effusion.
  • History of severe hypersensitivity.
  • Any previous TACE or TAE for HCC.
  • Any previous chemotherapy using epirubicin or CDDP.
  • Complications as below (except chronic hepatitis or liver cirrhosis)
  • Severe heart disease
  • Myocardial infarction within 6 months
  • Renal insufficiency
  • Active infections (except virous hepatitis)
  • Gastrointestinal bleeding
  • Active double cancer
  • Hepatic encephalopathy or heavy mental disorder.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Digestive Surgery, Nihon University School of Medicine

tabashi City, Tokyo, 173-8610, Japan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

EpirubicinCisplatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Tadatoshi Takayama, M.D.

    Digestive Surgery Nihon University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Masashi Fujii, MD

CONTACT

+81332981711masashi.fujii@gioncology.jp

Tadatoshi Takayama, MD

CONTACT

+81339728111Takayama.Tadatoshi@nihon-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2012

Study Completion

February 1, 2015

Last Updated

October 19, 2012

Record last verified: 2012-10

Locations

JP(1)