Biliary Tract Cancer
Conditions
Brief summary
To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after hemihepatectomy.
Detailed description
There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day 1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. Formerly, the investigators planned the study to decide more safety adjuvant protocol (recommend dose: RD) for Gemcitabine or S-1 after hemihepatectomy using Continuous Reassessment Method (CRM) analysis and decided the recommend doses. Note: In the former study, the investigators decided that tolerable ratio of Dose Limiting Toxicity (DLT) would be less than 10%. Herein, the investigators planned the study to evaluate efficacy (recurrent free survival as primary outcome, and overall-survival as secondary outcome) and safety (as secondary outcome) in our recommended protocols, and to compare the efficacy as randomized control trial.
Interventions
DRUGGemcitabine
1000mg/m2, day 1 every 2 weeks
DRUGS-1
80mg/m2/day, day 1-28, every 6 weeks
Sponsors
Kansai Hepatobiliary Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Biliary tract cancer (BTC) (\>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma 2. R0 or R1 resection 3. no obvious recurrent lesion 4. 20 years old or more 5. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 6. The patient underwent no other treatment than surgery for BTC 7. Neutrophil must be over 1500/μl, Hemoglobin must be over 9.0g/dL, platelet must be over 100,000/μl, Aspartate transaminase (AST) and Alanine aminotransferase (ALT) must be less than 150 IU/L, total bilirubin must be less than 1.5 mg/dL, Creatinine must be less than 1.2 mg/dl, and Creatinine clearance must be over 60 mL/min 8. The patient can intake drugs per os. 9. From 4 to 12 weeks after the surgery 10. Written informed consent
Exclusion criteria
1. Existence of active double cancer 2. The patient suffered from severe drug allergy 3. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on) 4. Any active infections exist. 5. Pregnancy 6. Severe mental disorder 7. Others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 year recurrent free survival rate | One year | Duration: From randomization to evidenced recurrence or death. Rate: Number of patients with evidenced recurrence or death / number of total patients. 1 year recurrent free survival rate: recurrent free survival rate at one-year from the randomization |
Secondary
| Measure | Time frame |
|---|---|
| Two-year recurrent free survival rate | Two years |
| One-year overall survival rate | One year |
| Two-year overall survival rate | Two years |
| Duration of overall survival | an expected average of 3 years |
| Dose intensity of anti-tumor drugs | 6 months |
| Rate and grade of adverse events or adverse drug reactions | 6 months |
| Duration of recurrent free survival | an expected average of 2 years |
| Completion rate of the protocol treatment | 6 months |
Countries
Japan
Outcome results
None listed