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Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation

Primary Purpose

Liver Transplantation, Hepatocellular Carcinoma, Tumor Recurrence and Metastasis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
gemcitabine and oxaliplatin
doxorubicin, 5-Fu and cisplatin
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplantation

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Shanghai First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

gemcitabine and oxaliplatin

doxorubicin, 5-Fu and cisplatin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative survival
Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death.

Full Information

First Posted
May 17, 2010
Last Updated
May 17, 2010
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01125020
Brief Title
Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Changzheng Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Hepatocellular Carcinoma, Tumor Recurrence and Metastasis, Survival, Adjuvant Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine and oxaliplatin
Arm Type
Active Comparator
Arm Title
doxorubicin, 5-Fu and cisplatin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
gemcitabine and oxaliplatin
Intervention Description
Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.
Intervention Type
Drug
Intervention Name(s)
doxorubicin, 5-Fu and cisplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
tumor recurrence and metastasis
Description
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
Time Frame
within the first year after liver transplantation
Secondary Outcome Measure Information:
Title
Postoperative survival
Description
Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death.
Time Frame
within the first year after liver transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Yi Wu, MM
Phone
0086-021-63240090
Ext
3136
Email
wjy8541@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Hai Peng, MD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Hai Peng, MD
Phone
0086-021-63240090
Ext
3132
Email
pengpzh@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jun-Wei Fan, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19857695
Citation
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.
Results Reference
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PubMed Identifier
16573544
Citation
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.
Results Reference
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PubMed Identifier
17330837
Citation
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.
Results Reference
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Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation

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