Randomized Phase II study of adjuvant chemotherapy with gemcitabine plus cisplatin versus gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy - KHBO1901

Yanagimoto Hiroaki0 sites106 target enrollmentAugust 23, 2019

Overview

No summary available.

Registry

who.int

Start Date

August 23, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Yanagimoto Hiroaki

•1\) Pathological disease stage according to the UICC classification, seventh Edition: T2\-4, N0, M0 or T1\-4, N1, M0 (for patients with EHBD, GB or AV cancer), or T1\-4, N0\-1, M0 (for patients with IHBD cancer).in resected specimen.
•2\) R0 or R1 residual disease. No recurrence on contrast\-enhanced or plain computed tomography(CT) of the chest and abdomen within 28 days before registration.
•3\) Age over 20 years
•4\) ECOG performance status 0 or 1
•5\) No treatment other than surgery except of drainage
•6\) Adequate organ functions
•a) Neutrophil count \>\=1,500/mm3
•b) Platelet count \>\=100,000/mm3
•c) Serum aspartate transaminase \<\= 150U/L
•d) Serum alanine transaminase\<\= 150U/L

•1\) Distant metastasis except of positive CY
•2\) Not performed lobectomy
•3\) Other concurrent active cancer (synchronous double cancer or heterochronous double cancer with a disease\-free interval of 3 years or shorter, excluding lesions consistent with intraepithelial cancer, i.e., intramucosal cancer that are assessed as cured by endoscopical treatment.
•4\) Patients with a history of severe drug hypersensitivity or drug allergy.
•5\) Serious complicating disorders (Interstitial pneumonia, pulmonary fibrosis or severe emphysema, hepatic cirrhosis, uncontrollable\-diabetes, cardiac disease, renal failure, liver failure, hemorrhagic peptic ulcer etc).
•6\) Active infection requiring systemic therapy
•7\) Pregnant or lactating women, women with childbearing potential, males who wish a pregnancy of his partner.
•8\) Severe psychiatric disease.
•9\) Inappropriate for this study judged by the attending physician