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Randomized Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

Phase 2
20 Years
Open (Enrolling)
Biliary Tract Cancer

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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

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:


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:


Principal Investigator

Hiroaki Nagano, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Osaka University, Graduate School of Medicine


Japan: Institutional Review Board

Study ID:




Start Date:

January 2013

Completion Date:

December 2016

Related Keywords:

  • Biliary Tract Cancer
  • Biliary Tract Neoplasms