biliary tract cancer
Conditions
Interventions
Adjuvant GC chemotherapy consisted of intravenous GEM(1000mg/mm2) and CDDP (25mg/m2) on days 1 and 8, with 1 week rest.
Adjuvant GS chemotherapy consisted of intravenous GEM(800mg/mm2) on days 1 a
Sponsors
Kansai Hepatobiliary Oncology Group (KHBO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as having biliary tract adenocarcinoma or adenosquamous carcinoma(IHBD, EHBD, GB or AV cancer) in resected specimen. 2) R0 or R1 residual disease. 3) 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). 4) Age over 20 years 5) ECOG performance status 0 or 1 6)No treatment other than surgery except of drainage 7) No distant metastasis according to the radiological findings after operation. 8) 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 9) Adequate oral intake. 10) Between 3 and 12 weeks after resection. 11) Written informed consent.
Exclusion criteria
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 males who wish a pregnancy of his partner. 8) Severe psychiatric disease. 9) Inappropriate for this study judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival (2-year recurrence-free survival rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTatsuya Ioka
Kansai Hepato-Biliary Oncology Group (KHBO) Department of Cancer Survey and Gastrointestinal Oncology,Osaka International Cancer Institute
Outcome results
None listed