NCT00225290

Brief Summary

To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
230

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

October 12, 2011

Status Verified

September 1, 2005

First QC Date

September 21, 2005

Last Update Submit

October 7, 2011

Conditions

Carcinoma, Hepatocellular

Keywords

Phase IIIHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • overall survival

Interventions

Thalidomide(Thado)DRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with measurable, metastatic or locally advanced hepatocellular carcinoma
  • The diagnosis of HCC should be established either by cyto/histology
  • Patients must be \> 20 years of age.
  • ECOG score \< 2.
  • Signed informed consent.
  • Female patients at child-bearing age must have negative pregnancy test.

You may not qualify if:

  • Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
  • Patients with advanced second primary malignancy are not eligible.
  • Patients with active infection are not eligible.
  • Patients with pregnancy or breast-feeding are not eligible.
  • Patients with brain metastases are not eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan Cooperative Oncology Group

Taipei, Taiwan

Location

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

  • Li-Tzong Chen, M.D Ph.D.

    Division of Cancer Research, National Health Research Institute Ward 191

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

February 1, 2003

Last Updated

October 12, 2011

Record last verified: 2005-09

Locations

TW(1)