Capecitabine to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Fudan University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00561522
First received: November 20, 2007
Last updated: July 20, 2010
Last verified: August 2009
  Purpose

The purpose of this study is to determine whether capecitabine is effective to prevent disease recurrence after curative hepatic resection in patients with hepatocellular carcinoma.


Condition Intervention Phase
Hepatocellular Carcinoma
Neoplasm Metastasis
Drug: Capecitabine
Other: No other preventive treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Capecitabine as Adjuvant Chemotherapy to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • The primary end point was to determine the effect on disease-free survival and overall survival by oral capecitabine. [ Time Frame: four years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary end point was to analyze the relationship between preventive effectiveness of capecitabine with thymidine phosphorylase expression level of tumor tissue. [ Time Frame: four years ] [ Designated as safety issue: No ]

Estimated Enrollment: 290
Study Start Date: November 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention treatment
Capecitabine
Drug: Capecitabine
Capecitabine 1,250 mg/m2 twice daily on days 1-14, followed by a 7-day drug-free interval. Treatment repeats every 21 days. The above cycle is repeated for 4-6 times.If disease recurrence or unacceptable toxicity or other criteria for withdrawal are met, treatment will be stopped.
No Intervention: No intervention treatment
No other preventive treatment
Other: No other preventive treatment
No other preventive treatment

Detailed Description:

Hepatocellular carcinoma (HCC) accounts for 70-90% of primary liver cancers, which is the third most common cause of death from cancer worldwide; over half a million new cases are diagnosed worldwide each year. Hepatic resection has been established as one of the most effective and safe therapeutic options for HCC. However, recurrence, particularly metastatic recurrence, is one of the major obstacles to long-term survival. Several adjuvant treatments have been used to prevent recurrence after surgery, but their effectiveness remains controversial. Fluorouracil (FU), an antimetabolite, is a commonly used chemotherapeutic agent, with activity in a variety of solid tumors including those of the head and neck, breast, prostate, pancreas, liver, and genitourinary and gastrointestinal tracts. Capecitabine (Xeloda; Roche), a novel prodrug of 5-FU, is an orally administered tumor-selective cytotoxic agent that is converted to 5-FU by three enzymes. Capecitabine has the advantages of convenient oral administration and of mimicking the effect of protracted intravenous (i.v.) 5-FU. Capecitabine is currently approved by the FDA for use as first-line therapy in patients with metastatic colorectal cancer when single-agent fluoropyrimidine therapy is preferred. The drug is also approved for use as a single agent in metastatic breast cancer patients who are resistant to both anthracycline- and paclitaxel-based regimens or in whom further anthracycline treatment is contraindicated. Our previous study found that PD-ECGF mRNA was highly expressed in human HCC and particularly in portal vein tumor thrombus as compared with noncancerous liver tissues. Capecitabine inhibits tumor growth and metastatic recurrence after resection of HCC in highly metastatic nude mice model. The effect of capecitabine may be attributed to the high expression of PD-ECGF in tumors. The antitumor activity of single-agent capecitabine was modest in patients with HCC, including those with cirrhosis. Von Delius et al reported that capecitabine was found to be safe for treatment of patients with HCC, including those with compensated cirrhosis. On the basis of previous findings, we designed a randomized, controlled trial to test the hypothesis that adjuvant postoperative chemotherapy with capecitabine can prevent tumor recurrence after radical hepatic resection in patients with HCC. Because capecitabine is administered orally, we considered that this treatment would be clinically useful if its effectiveness could be confirmed.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First curative hepatic resection
  • Hepatocellular Carcinoma (histologically confirmed)
  • Cirrhosis of Child-Pugh class A or B
  • A performance status ≤ 2
  • Adequate bone marrow ,hepatic and renal functions (white blood cell (WBC) count > 2.5×10^3/μL, platelet count > 40×10^3/μL, a serum bilirubin level, alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 times the upper limit of the normal value, and serum creatinine level < 1.5 mg/dL)
  • Major organ (heart, lung and brain) function was normal
  • An age between 18 and 79 years.

Exclusion Criteria:

  • Any active infectious process
  • Known hypersensitivity to capecitabine
  • The presence of clinically confirmed extrahepatic metastasis, macroscopic evidence of tumor thrombus in the inferior vena cava or the main portal vein or the main bile duct
  • Other previous or synchronous malignant disorders
  • Postoperative dysfunction of any organ.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561522

Locations
China, Shanghai
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Study Director: Jian Zhou, M.D. Fudan University
  More Information

No publications provided

Responsible Party: Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT00561522     History of Changes
Other Study ID Numbers: 2007-07-RCT-LCI1
Study First Received: November 20, 2007
Last Updated: July 20, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Recurrence
Metastasis
Hepatocellular Carcinoma
Radical Hepatic Resection
Drug Prevention
Capecitabine
Surgery

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasm Metastasis
Recurrence
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Disease Attributes
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014