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NCT Number: NCT02182778

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

To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyoto University Hospital

Kyoto, 606-8507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cytologically or histologically proved biliary tract cancer
  • age >=20 years
  • Performance Status (PS) 0-2
  • No prior history of chemotherapy or radiotherapy.
  • 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)
  • Adequate oral intake
  • Provided written informed consent -

Exclusion criteria

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

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Treatment and study plan

Gemcitabine/Cisplatin

Drug

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

Other names: Gemcitabine;gemzer, Cisplatin;Cispulan

Gemcitabine/Cisplatin /S-1

Drug

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,

Primary outcomes

  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 outcomes

  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 .

Sponsors and collaborators

Lead sponsor

Kansai Hepatobiliary Oncology Group

Network

Registry information

Official study title

Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jul 8, 2014
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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