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

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

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Overall survival rate

Secondary Outcome

 Response rate

Condition

Biliary Tract Cancer

Intervention

Gemcitabine/Cisplatin

Study Arms / Comparison Groups

 Gemcitabine/Cisplatin group

Description:  Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

246

Start Date

July 9, 2014

Completion Date

April 16, 2018

Primary Completion Date

February 4, 2016

Eligibility 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

             -
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Masashi Kanai, , 

Location Countries

Japan

Location Countries

Japan

NCT ID

NCT02182778

Organization ID

KHBO1401

Secondary IDs

UMIN 000014371

Responsible Party

Sponsor

Study Sponsor

Kansai Hepatobiliary Oncology Group

Study Sponsor

Masashi Kanai, Study Director, Kyoto University

Verification Date

April 2018