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

Phase 3

Completed

• Conditions: Biliary Tract Cancer
• Interventions: Drug: Gemcitabine/Cisplatin /S-1; Drug: Gemcitabine/Cisplatin

• Registration Number: NCT02182778
• Lead Sponsor: Kansai Hepatobiliary Oncology Group

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 Timeline

• Study First Submitted: 2014-06-28
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-08
• Study Start: 2014-07-09
• Primary Completion: 2016-02-04
• Status Verified: 2018-04
• Study Completion: 2018-04-16
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine/Cisplatin group	Gemcitabine/Cisplatin /S-1	Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
Gemcitabine/Cisplatin /S-1 group	Gemcitabine/Cisplatin	S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.

Primary Outcome Measures

Name	Time	Method
Overall survival rate	Probability of 1-year survival (%)	The primary endpoint is designated to evaluate overall survival rate at 12-month.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety	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 .
Progression free survival	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.
Response rate	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.

Trial Locations

Locations (1)

Kyoto University Hospital; 🇯🇵 Kyoto, Japan