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History of Changes for Study: NCT02182778
GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer
Latest version (submitted February 19, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 7, 2014 None (earliest Version on record)
2 August 31, 2016 Recruitment Status, Study Status and Study Design
3 October 5, 2017 Study Status
4 February 19, 2019 Recruitment Status, Study Status and Contacts/Locations
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Results Submission Events
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Study NCT02182778
Submitted Date:  July 7, 2014 (v1)
Open or close this module Study Identification
Unique Protocol ID: KHBO1401
Brief Title: GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer
Official Title: Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer
Secondary IDs: UMIN 000014371 [Registry Identifier: UMIN]
Open or close this module Study Status
Record Verification: July 2014
Overall Status: Enrolling by invitation
Study Start: June 2014
Primary Completion: May 2017 [Anticipated]
Study Completion: May 2019 [Anticipated]
First Submitted: June 28, 2014
First Submitted that
Met QC Criteria:		 July 7, 2014
First Posted: July 8, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:		 July 7, 2014
Last Update Posted: July 8, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Kansai Hepatobiliary Oncology Group
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.
Detailed Description: Gemcitabine/cisplatin combination therapy (GC) has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). Investigators have evaluated the efficacy and safety of gemcitabine/cisplatin/S-1 combination therapy (GCS) for patients with advanced BTC and observed the promising efficacy. In this randomized phase Ⅲ study, investigators aimed to compare GCS with GC in patients with advanced BTC.
Open or close this module Conditions
Conditions: Biliary Tract Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 220 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Gemcitabine/Cisplatin group
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
 Drug: Gemcitabine/Cisplatin /S-1
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
Other Names:
  • Gemcitabine;gemzer, Cisplatin;Cispulan S-1;TS-1,
Experimental: Gemcitabine/Cisplatin /S-1 group
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
 Drug: Gemcitabine/Cisplatin
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
Other Names:
  • Gemcitabine;gemzer, Cisplatin;Cispulan
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall survival rate
[ Time Frame: Probability of 1-year survival (%) ]

The primary endpoint is designated to evaluate overall survival rate at 12-month.
Secondary Outcome Measures:
1. Response rate
[ Time Frame: Every 3 months, up to 24 months ]

The investigators will conduct CT test every 3 months in order to measure the tumor size of each patient and evaluate the best tumor response according to RECIST criteria.
2. Progression free survival
[ Time Frame: Every 3 months, up to 24 months ]

In oredr to research the progression survival, the investigators will check the presence of progression disease for each patient every three months.
3. Number of Participants with Adverse Events as a Measure of Safety
[ Time Frame: 24 months ]

The investigators will examine the frequency and the degree of each side effect that will appear to the patient at each course of chemotherapy .
Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Patients with cytologically or histologically proved biliary tract cancer
  2. age >=20 years
  3. Performance Status (PS) 0-2
  4. No prior history of chemotherapy or radiotherapy.
  5. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count >=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and renal function (creatinine clearance >=45 mL/min)
  6. Adequate oral intake
  7. Provided written informed consent -

Exclusion Criteria:

  1. Patients with interstitial pneumonia or pulmonary fibrosis
  2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months
  3. Patients with severe active infection
  4. Patients with moderate or marked pleural effusion or ascites necessitating drainage
  5. Patients with a history of severe drug allergy
  6. Patients with other serious comorbid disease
  7. Patients who are pregnant or lactating, or have an intention to get pregnant
  8. Patients with mental disease
  9. Patients who are judged inappropriate for the entry into the study by the principle doctor

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Open or close this module Contacts/Locations
Study Officials: Masashi Kanai
Study Director
Kyoto University Hospital
Locations: Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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