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GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182778
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Kansai Hepatobiliary Oncology Group

Study Description
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Brief Summary:
To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Gemcitabine/Cisplatin Drug: Gemcitabine/Cisplatin /S-1 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer
Actual Study Start Date : July 9, 2014
Actual Primary Completion Date : February 4, 2016
Actual Study Completion Date : April 16, 2018

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Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: Gemcitabine;gemzer, Cisplatin;Cispulan


Outcome Measures
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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 .


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182778


Locations
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Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kansai Hepatobiliary Oncology Group
Investigators
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Study Director: Masashi Kanai Kyoto University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kansai Hepatobiliary Oncology Group
ClinicalTrials.gov Identifier: NCT02182778    
Other Study ID Numbers: KHBO1401
UMIN 000014371 ( Registry Identifier: UMIN )
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: April 2018
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
 Cisplatin
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action