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:


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:
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 April 14, 2014