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

JRCT ID: jRCTs051190040

Registered date:23/08/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: biliary tract cancer
• Date of first enrollment: 29/08/2019
• Target sample size: 106
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Recurrence-free survival (2-year recurrence-free survival rate)

Secondary Outcome

1)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 maximum: Not applicable
• Gender: Both

Include criteria

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
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 criteria

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

Related Information

• Primary Sponsor: Yanagimoto Hiroaki
• Secondary Sponsor: Ioka Tatsuya
• Secondary ID(s): UMIN000036449