Randomized Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
20 Years
N/A
Both
Biliary Tract Cancer
Trial Information
Randomized Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
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 CRM (continual reassessment method) analysis and decided the recommend
doses. Note: In the former study, the investigators decided that tolerable ratio of 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.
Inclusion Criteria:
1. Biliary tract cancer (>= UICC Stage IB), adenocarcinoma
2. R0 or R1 resection
3. no obvious recurrent lesion
4. 20 years old or more
5. 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, AST and 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1 year recurrent free survival rate
Outcome Description:
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
Outcome Time Frame:
One year
Safety Issue:
Yes
Principal Investigator
Hiroaki Nagano, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Osaka University, Graduate School of Medicine
Authority:
Japan: Institutional Review Board
Study ID:
KHBO1208
NCT ID:
NCT01815307
Start Date:
January 2013
Completion Date:
December 2016
Related Keywords:
- Biliary Tract Cancer
- Biliary Tract Neoplasms
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