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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182778
• Other study ID #: KHBO1401
• Secondary ID: UMIN 000014371
• Status: Completed
• Phase: Phase 3
• Start date: July 9, 2014
• Est. completion date: April 16, 2018

Study information

• Verified date: April 2018
• Source: Kansai Hepatobiliary Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: April 16, 2018
• Est. primary completion date: February 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• Gemcitabine/Cisplatin
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
• 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.

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kansai Hepatobiliary Oncology Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	The primary endpoint is designated to evaluate overall survival rate at 12-month.	Probability of 1-year survival (%)
Secondary	Response rate	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.	Every 3 months, up to 24 months
Secondary	Progression free survival	In oredr to research the progression survival, the investigators will check the presence of progression disease for each patient every three months.	Every 3 months, up to 24 months
Secondary	Number of Participants with Adverse Events as a Measure of Safety	The investigators will examine the frequency and the degree of each side effect that will appear to the patient at each course of chemotherapy .	24 months