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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Shanghai Changzheng Hospital

Information provided by:

Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT01125020

First received: May 17, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Purpose

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.

Condition	Intervention
Liver Transplantation Hepatocellular Carcinoma Tumor Recurrence and Metastasis Survival Adjuvant Chemotherapy	Drug: gemcitabine and oxaliplatin Drug: doxorubicin, 5-Fu and cisplatin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Transplantation

Drug Information available for: Fluorouracil Cisplatin Doxorubicin Doxorubicin hydrochloride Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:

tumor recurrence and metastasis [ Time Frame: within the first year after liver transplantation ] [ Designated as safety issue: No ]
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 [ Time Frame: within the first year after liver transplantation ] [ Designated as safety issue: Yes ]
Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death.

Estimated Enrollment:	150
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: gemcitabine and oxaliplatin	Drug: gemcitabine and oxaliplatin Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.
Active Comparator: doxorubicin, 5-Fu and cisplatin	Drug: doxorubicin, 5-Fu and cisplatin 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125020

Contacts

Contact: Jun-Yi Wu, MM

0086-021-63240090 ext 3136

wjy8541@126.com

Locations

China, Shanghai
Shanghai First People's Hospital	Recruiting
Shanghai, Shanghai, China, 200080
Contact: Zhi-Hai Peng, MD 0086-021-63240090 ext 3132 pengpzh@hotmail.com
Principal Investigator: Jun-Wei Fan, MD

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Shanghai Changzheng Hospital

Investigators

Study Chair:

Zhi-Hai Peng, MD

Shanghai First People's Hospital

More Information

Publications:

Dudek K, Kornasiewicz O, Remiszewski P, Kobry? K, Ziarkiewicz-Wróblewska B, Górnicka 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.

Söderdahl G, Bäckman L, Isoniemi H, Cahlin C, Höckerstedt K, Broomé U, Mäkisalo 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.

Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taïeb 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.

Responsible Party:	Shanghai First People's Hosptial
ClinicalTrials.gov Identifier:	NCT01125020 History of Changes
Other Study ID Numbers:	2008BAI60B03
Study First Received:	May 17, 2010
Last Updated:	May 17, 2010
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:

Carcinoma
Neoplasm Metastasis
Recurrence
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Disease Attributes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases

Liver Diseases
Gemcitabine
Oxaliplatin
Cisplatin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents

ClinicalTrials.gov processed this record on May 21, 2013

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