Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

This study has been terminated.
(Planning for randomized phase III trial for this issue.)
Sponsor:
Collaborators:
Samsung Medical Center
Dong-A University
Chung-Ang University
Information provided by:
Gyeongsang National University Hospital
ClinicalTrials.gov Identifier:
NCT01096745
First received: March 30, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.


Condition Intervention Phase
Metastatic Biliary Tract Cancer
Locally Advanced Biliary Tract Cancer
Drug: Gemcitabine, Cisplatin
Drug: S-1, Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients

Resource links provided by NLM:


Further study details as provided by Gyeongsang National University Hospital:

Primary Outcome Measures:
  • Time to progression [ Time Frame: From the assigned day to the disease progression or the last day of follow-up without progression. Clinically assessment would be done every cycle (month) and radiologically assessed every 6 weeks with CT scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate Overall survival Safety profile [ Time Frame: Overall survival is measured from the first day of assignment until death or the last day of the follow-up.Clinically assessment would be done every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 78
Study Start Date: July 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine/Cisplatin Drug: Gemcitabine, Cisplatin
D1,D8 Gemcitabine 1000mg/m2 + N/S 150cc miv over 30mins D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins repeated every 3weeks
Other Names:
  • Gemcitabine - Gemcitane
  • Cisplatin - Cispulan
Experimental: S-1/Cisplatin
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
Drug: S-1, Cisplatin
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
Other Names:
  • S-1; TS-1
  • Cisplatin ; Cispulan

Detailed Description:

Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to the difficulty associated with performing clinical trials in this field.

Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age : older than 20
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
  • Histologically confirmed adenocarcinoma of the biliary tract
  • Metastatic or unresectable biliary cancer
  • No prior chemotherapy for biliary cancer
  • A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
  • Adequate bone marrow, liver, renal function

Exclusion Criteria:

  • A patient with no measurable disease
  • A patient who received previous palliative chemotherapy for biliary cancer
  • A patient who received adjuvant chemotherapy for biliary cancer within 1year
  • A patient with previous active or passive immunotherapy.
  • A pregnant or lactating patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096745

Locations
Korea, Republic of
Gyeongsang University Hospital
Jinju, Gyeongsang Namdo, Korea, Republic of, 660-702
Sponsors and Collaborators
Gyeongsang National University Hospital
Samsung Medical Center
Dong-A University
Chung-Ang University
Investigators
Principal Investigator: Hyuk-Chan Kwon, M.D. Dong-A University Hospital
Study Director: Jung Hun Kang, M.D. Gyeongsang University Hospital
  More Information

No publications provided

Responsible Party: Jung Hun Kang/Assisstant Professor, Gyeongsang National University Hospital
ClinicalTrials.gov Identifier: NCT01096745     History of Changes
Other Study ID Numbers: GNUHIRB-2010-5
Study First Received: March 30, 2010
Last Updated: June 21, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Gyeongsang National University Hospital:
Gemcitabine
Cisplatin
S-1
bile duct cancer

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014