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

ClinicalTrials.gov processed this record on October 21, 2014