NCT01055743

Brief Summary

This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 26, 2010

Status Verified

January 1, 2010

Enrollment Period

5 years

First QC Date

January 22, 2010

Last Update Submit

January 24, 2010

Conditions

Early Stage Hepatocellular Carcinoma

Keywords

Fluorouracil ImplantsHepatocellular carcinomaRadical resection

Outcome Measures

Primary Outcomes (1)

  • To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS).

    1, 2, and 3 years

Secondary Outcomes (3)

  • Quality of Life

    from baseline to the last visit

  • Incidence Rate of Complications

    1, 2, and 3 years

  • Adverse Events

    from the beginning of treatment to the end of study

Study Arms (2)

Radical resection + Fluorouracil Implants

EXPERIMENTAL
Procedure: Radical resectionDrug: Fluorouracil Implants

Radical resection

ACTIVE COMPARATOR
Procedure: Radical resection

Interventions

Radical resectionPROCEDURE

Radical resection of hepatocellular carcinoma

Radical resectionRadical resection + Fluorouracil Implants
Fluorouracil ImplantsDRUG

Implanted during the surgical treatment

Radical resection + Fluorouracil Implants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological diagnosis of stage I hepatocellular carcinoma
  • Child-Pugh class A, B
  • Radical resection is feasible
  • Patients with adequate renal, hepatic, and hematologic function
  • Written informed consent

You may not qualify if:

  • Allergic to chemotherapy drugs
  • No measurable lesion
  • Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment
  • Evidence of serious infection
  • Renal or hepatic dysfunction, significant cardiovascular disease
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, 200438, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Shuqun Cheng, MD

    Eastern Hepatobiliary Surgery Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuqun Cheng, MD

CONTACT

86-021-81875251

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 26, 2010

Study Start

August 1, 2009

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 26, 2010

Record last verified: 2010-01

Locations

CN(1)