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Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00817895
First received: January 4, 2009
Last updated: January 6, 2009
Last verified: January 2009
  Purpose

Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly influence it's prognosis, especially for the patient with tumor >5cm, multiple tumor and who cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted into the liver incisal margin after tumor was resected could reduce the recurrence rate of HCC after liver resection.According to this, we proceed this RCT to prospectively observe the effect of sustained released 5-FU,and we also want to know whether combined with sustained released cisplatin will get better effect in preventing the tumor recurrence,especially in short time after liver resection.


Condition Intervention
Hepatocellular Carcinoma
Drug: sustained released 5-FU and sustained released cisplatin
Drug: sustained released 5-FU
Procedure: TACE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-Term Recurrence

Resource links provided by NLM:


Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-FU+Cisplatin
50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected.
Drug: sustained released 5-FU and sustained released cisplatin
600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.
Other Name: 5-FU+Cisplatin group
Procedure: TACE
All patients will accept TACE one month after tumor was resected.
Other Name: Postoperative TACE
Active Comparator: 5-FU
50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected.
Drug: sustained released 5-FU
600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.
Other Name: 5-FU group
Procedure: TACE
All patients will accept TACE one month after tumor was resected.
Other Name: Postoperative TACE
Experimental: control Procedure: TACE
All patients will accept TACE one month after tumor was resected.
Other Name: Postoperative TACE

Detailed Description:

150 HCC patients with tumor >5cm, multiple tumor and who cannot accept R0 resection will be randomized divided into 3 groups. Group A (50 cases) will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected. Group B (50 cases) will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin. Group C (50 cases) will be the controlled one which will not be implanted any chemotherapeutic drugs. All patients will accepted TACE 30 days after liver resection. We will follow up all patients until they are dead or missed connected. Related adverse reaction will be recorded. Total survival time (TST) and disease free survival time (DFST) will be calculated too. At the end of the study we will compare the difference of adverse reaction, complication, TST and DFST between the 3 groups. According to the result we will estimate these drugs' antitumor effect and safety.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. tumor >5cm;
  2. multiple tumor located in one liver lobe;
  3. margin of tumor is not clear;
  4. cutting edge to tumor <1cm;
  5. portal vein branch invasion;
  6. without extra-liver metastasis;
  7. patient's liver function and condition is able to accept hepatectomy.

Exclusion Criteria:

  1. single tumor <=5cm;
  2. multiple tumor located more than in one liver lobe;
  3. margin of tumor is clear;
  4. cutting edge to tumor >=1cm;
  5. portal vein stem invasion
  6. extra-liver metastasis;
  7. patient's liver function and condition cannot accept hepatectomy.
  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: NCT00817895

Contacts
Contact: Feng Xu, MD. 86-21-25070773 victorf2255@hotmail.com
Contact: Jiamei Yang, MD. 86-21-25070808

Locations
China, Shanghai
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, Shanghai, China, 200438
Contact: Yangqing Huang    86-21-65564166-75493    erdyhuang@vip.163.com   
Contact: Jiamei Yang, MD.    86-21-25070808      
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Shen Feng, MD. Eastern Hepatobiliary Surgery Hospital
  More Information

No publications provided

Responsible Party: XuFeng, Department of special treatment , Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00817895     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-010
Study First Received: January 4, 2009
Last Updated: January 6, 2009
Health Authority: China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
hepatocellular carcinoma
liver resection
intraoperative chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Disease Attributes
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014