Overview

This trial is active, not recruiting.

Condition biliary tract cancer
Treatments gemcitabine/cisplatin, gemcitabine/cisplatin /s-1
Phase phase 3
Sponsor Kansai Hepatobiliary Oncology Group
Start date June 2014
End date May 2017
Trial size 246 participants
Trial identifier NCT02182778, KHBO1401, UMIN 000014371

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
gemcitabine/cisplatin /s-1 Gemcitabine;gemzer, Cisplatin;Cispulan S-1;TS-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.
(Experimental)
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
gemcitabine/cisplatin Gemcitabine;gemzer, Cisplatin;Cispulan
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.

Primary Outcomes

Measure
Overall survival rate
time frame: Probability of 1-year survival (%)

Secondary Outcomes

Measure
Response rate
time frame: Every 3 months, up to 24 months
Progression free survival
time frame: Every 3 months, up to 24 months
Number of Participants with Adverse Events as a Measure of Safety
time frame: 24 months

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Kansai Hepatobiliary Oncology Group.