NIPH Clinical Trials Search

JRCT ID: jRCTs051190040

Registered date:23/08/2019

Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedbiliary tract cancer
Date of first enrollment29/08/2019
Target sample size106
Countries of recruitment
Study typeInterventional
Intervention(s)Arm A: Adjuvant GC chemotherapy consisted of intravenous GEM(1000mg/mm2) and CDDP (25mg/m2) on days 1 and 8, with 1 week rest. Arm B: Adjuvant GS chemotherapy consisted of intravenous GEM(800mg/mm2) on days 1 and 8, and oral S-1(50mg/mm2/day) administered twice daily on days 1-14, with a 1 week rest.


Primary OutcomeRecurrence-free survival (2-year recurrence-free survival rate)
Secondary Outcome1)Overall survival 2)Proportion of treatment completion 3)Relative dose intensity 4)Proportion of adverse events 5)Relapse-free survival rate and overall survival of lymph node positive/lymph node negative case 6)Relapse-free survival rate and overall survival of R0/R1 case 7)Relapse-free survival rate and overall survival of each primary site

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) 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 e) Serum total bilirubin <= 1.5 mg/dL f) Serum creatinine <= 1.2 mg/dL g) Creatinine clearance >=60 mL/min 7) Adequate oral intake. 8) Between 3 and 12 weeks after resection. 9) Written informed consent.
Exclude criteria1) 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

Related Information


Public contact
Name Daisuke Tsugawa
Address 7-5-2 Kusunoki, Chuo-ku, Kobe-shi, Hyogo, 541-8567 Japan Hyogo Japan 650-0017
Telephone +81-78-382-6302
Affiliation Kobe University Hospital
Scientific contact
Name Hiroaki Yanagimoto
Address 7-5-2 Kusunoki, Chuo-ku, Kobe-shi, Hyogo, 541-8567 Japan Hyogo Japan 650-0017
Telephone +81-78-382-6302
Affiliation Kobe University Hospital