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Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01429961
First received: September 6, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose
Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma

Condition Intervention Phase
Advanced Hepatocellular Carcinoma
Drug: SOX
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Time to progression (TTP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The time from study enrollment to tumor progression or death


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

  • response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    response rate by RECIST 1.1

  • toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    toxicity according to NCI-CTCAE v.3.0


Estimated Enrollment: 38
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOX
TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14
Drug: SOX
TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1~14

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • ECOG performance score of two or less
  • Child Pugh class A•
  • Histologically or cytologically confirmed HCC or clinical diagnosis of HCC when the following criteria are all met History of chronic hepatitis or cirrhosis of liver Typical features of HCC demonstrated in dynamic imaging studies, such as three phase computed tomography AFP level more than 200 ng/mL
  • presence of extrahepatic measurable lesion
  • no prior systemic therapy (excluding sorafenib)
  • adequate marrow, liver, kidney function
  • written informed consent

Exclusion Criteria:

  • prior systemic therapy (excluding sorafenib)
  • hypersensitivity to study drugs
  • active gastrointestinal bleeding
  • other malignancies within five years
  • pregnant or breastfeeding female
  • symptomatic brain or leptomeningeal metastasis
  • clinically significant heart disease
  • interstitial pneumonia
  • peripheral neuropathy grade one or more
  • uncontrolled infection
  • renal impairment
  • prior use of investigational drug or therapy within 4 weeks
  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: NCT01429961

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01429961     History of Changes
Other Study ID Numbers: H-1010-054-336 
Study First Received: September 6, 2011
Last Updated: September 6, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Oxaliplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 09, 2016