Overview

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

Status:
Completed

Trial end date:
2018-04-16

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Kansai Hepatobiliary Oncology Group

Treatments:

Cisplatin
Gemcitabine
S 1 (combination)
Tegafur

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

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