NCT01125020

Brief Summary

The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

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

Study Start

First participant enrolled

December 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 18, 2010

Status Verified

May 1, 2010

Enrollment Period

1.4 years

First QC Date

May 17, 2010

Last Update Submit

May 17, 2010

Conditions

Liver TransplantationHepatocellular CarcinomaTumor Recurrence and MetastasisSurvivalAdjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • tumor recurrence and metastasis

    Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy

    within the first year after liver transplantation

Secondary Outcomes (1)

  • Postoperative survival

    within the first year after liver transplantation

Study Arms (2)

gemcitabine and oxaliplatin

ACTIVE COMPARATOR
Drug: gemcitabine and oxaliplatin

doxorubicin, 5-Fu and cisplatin

ACTIVE COMPARATOR
Drug: doxorubicin, 5-Fu and cisplatin

Interventions

gemcitabine and oxaliplatinDRUG

Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.

gemcitabine and oxaliplatin
doxorubicin, 5-Fu and cisplatinDRUG

Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.

doxorubicin, 5-Fu and cisplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment.

You may not qualify if:

  • Age less than 18 years
  • Treatment with other postoperative adjuvant chemotherapy
  • Survival is less than 3 months after liver transplantation
  • Inability to provide written informed consent prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (3)

  • Dudek K, Kornasiewicz O, Remiszewski P, Kobryn K, Ziarkiewicz-Wroblewska B, Gornicka B, Zieniewicz K, Krawczyk M. Impact of tumor characteristic on the outcome of liver transplantation in patients with hepatocellular carcinoma. Transplant Proc. 2009 Oct;41(8):3135-7. doi: 10.1016/j.transproceed.2009.08.016.

    PMID: 19857695BACKGROUND

  • Soderdahl G, Backman L, Isoniemi H, Cahlin C, Hockerstedt K, Broome U, Makisalo H, Friman S, Ericzon BG. A prospective, randomized, multi-centre trial of systemic adjuvant chemotherapy versus no additional treatment in liver transplantation for hepatocellular carcinoma. Transpl Int. 2006 Apr;19(4):288-94. doi: 10.1111/j.1432-2277.2006.00279.x.

    PMID: 16573544BACKGROUND

  • Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taieb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. doi: 10.1002/cncr.22532.

    PMID: 17330837BACKGROUND

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrenceNeoplasm Metastasis

Interventions

GemcitabineOxaliplatinDoxorubicinFluorouracilCisplatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic ChemicalsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesUracilPyrimidinonesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Zhi-Hai Peng, MD

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Central Study Contacts

Jun-Yi Wu, MM

CONTACT

0086-021-63240090wjy8541@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 18, 2010

Study Start

December 1, 2008

Primary Completion

May 1, 2010

Study Completion

December 1, 2010

Last Updated

May 18, 2010

Record last verified: 2010-05

Locations

CN(1)