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

Phase 2

• Conditions: biliary tract cancer; Biliary tract cancer undergoing curative resection without major hepatectomy

• Registration Number: JPRN-jRCTs051190040
• Lead Sponsor: Yanagimoto Hiroaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified