Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma

NCT01088581 | Completed Phase 3 DMC

• 1 other identifier: 4-2005-0203
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Several adjuvant therapies have been attempted to reduce uni-centric, and intra- or extrahepatic recurrence after curative surgical resection for hepatocellular carcinoma (HCC). However, because the efficacy of such adjuvant therapy remains unclear, there is no standard postoperative therapy. The investigators investigated whether adjuvant hepatic arterial infusional chemotherapy with 5-fluorouracil (5-FU) and cisplatin reduces the recurrence of HCC after curative resection.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; hepatic arterial infusion chemotherapy; 5-fluorouracil; cisplatin; adjuvant chemotherapy; hepatectomy

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence rate and adverse events

  2-year

Secondary Outcomes (1)

• overall survival

  2-year

Study Arms (2)

Observation group

NO INTERVENTION

No adjuvant chemotherapy after resection

Adjuvant group

ACTIVE COMPARATOR

Adjuvant chemotherapy after resection

Drug: Adjuvant group

Interventions

Adjuvant group DRUG

Adjuvant chemotherapy (5FU and cisplatin) after resection

Also known as: Adjuvant chemotherapy after resection

Adjuvant group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age of 18 to 70 years old
• appropriate blood test results (white blood cells (WBCs) ≥3,000/mm3, platelet count ≥50,000/mm3, total bilirubin \<3mg/dl)
• a patient could enter this study if one of the following was fulfilled
• maximum diameter of HCC ≥5 cm,
• microvascular or bile duct invasion upon pathological examination,
• capsular invasion of HCC upon pathological examination, 4) Edmonson-Steiner grade III or IV.

You may not qualify if:

• patients with intra- or extrahepatic metastases at 4 weeks after resection
• Child-Pugh class B or C (n = 4)
• ECOG performance scale ≥2
• prior systemic chemotherapy, radiation, or locoregional therapy

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Seung Up Kim, MD

  Yonsei University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: January 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: February 2, 2012

Record last verified: 2012-01

Locations

KR (1)