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A Multicenter Phase II Trial of Pre-operative Chemotherapy With Gemcitabine/ Cisplatin /S-1 for Biliary Tract Cancers With Lymph Node Metastasis Diagnosed by FDG-PET

Phase 2
20 Years
Open (Enrolling)
Biliary Tract Cancer

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Trial Information

A Multicenter Phase II Trial of Pre-operative Chemotherapy With Gemcitabine/ Cisplatin /S-1 for Biliary Tract Cancers With Lymph Node Metastasis Diagnosed by FDG-PET

Biliary tract cancer is one of the most lethal malignancies worldwide, with surgery
representing the only potentially curative treatment for this disease. However, many
patients are diagnosed as far advanced stage, which is too late for curative resection, and
even if surgery can be performed, the likelihood of relapse is very high. Lymph node
metastasis is the most powerful prognostic factor in biliary tract cancer, which makes
accurate preoperative assessment of lymph node metastasis important for indication of
resection. However, the diagnostic accuracy, sensitivity, and specificity of conventional
imaging techniques, including computed tomography (CT) and magnetic resonance imaging (MRI),
seem to be insufficient for accurate detection of lymph node metastasis. Previously, the
investigators reported FDG-PET is useful for prediction of lymph node metastasis.

On the other hand, gemcitabine has been widely used to treat the patients with unresectable
or recurrent biliary tract cancer. In the ABC-02 study, the first prospective multicenter
phase III study in this field, the combination of gemcitabine/cisplatin was compared with
gemcitabine monotherapy and found that the combination regimen significantly prolonged MST
(from 8.1 to 11.7 months; P < 0.001). Gemcitabine/cisplatin combination therapy is now
considered to be the standard regimen for advanced biliary tract cancer. S-1 is an oral
fluoropyrimidine prodrug that has confirmed efficacy against various solid tumors, both
alone and in combination with other cytotoxic drugs. S-1 monotherapy has yielded good
results against advanced biliary tract cancer and gemcitabine/S-1 combination therapy has
yielded promising results with acceptable toxicity levels for patients with advanced biliary
tract cancer.

Furthermore, the investigators reported the safety and efficacy of adding S-1 to
gemcitabine/cisplatin combination regimen (GCS) for advanced biliary tract cancer.

In this study, the investigators evaluate the efficacy and the safety of pre-operative
chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node
metastasis by FDG-PET

Inclusion Criteria:

1.Patients with radiologically proven biliary tract cancer. 2.No
extrahepatic disease. 3.No prior therapy. 4.The function of the liver is kept as satisfied
after hepatectomy. 5.No chronic liver damage. 6.Patients of age over 20 years. 7.ECOG
performance status of 0-1. 8.Sufficient organ function (neutrophil count >=1,500/mm3 and
platelet count >=100,000/mm3, Hemoglobin >=9.0g/dL, AST/ALT <=150 IU/L, total bilirubin
<=1.5 mg/dL , creatinine <=1.2 mg/dL , creatinine clearance >=60 mL/min) 9.Patients
obtained written informed consent.


Exclusion Criteria:1. Massive abdominal effusion requiring treatment. 2. Active
concomitant malignancy. 3. The case suspected of infection. 4. Patients with water
solubility diarrhea. 5. Mental disease or psychotic manifestation. 6. Under continuous
steroid therapy. 7. Patients with acute myocardial infarction. 8. Patients with severe
complications. 9. Pregnancy or the desire to preserve fecundity. 10. Serious drug
hypersensitivity or a history of drug allergy. 11. Any patients judged by the investigator
to be unfit to participate in the study.


Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Curative resection rate

Outcome Description:

The primary endpoint is designated to evaluate curative resection rate after pre-operative chemotherapy with GCS for Biliary Tract Cancers with lymph node metastasis diagnosed by FDG-PET.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Etsuro Hatano, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Kyoto University


Japan: Institutional Review Board

Study ID:




Start Date:

March 2013

Completion Date:

February 2019

Related Keywords:

  • Biliary Tract Cancer
  • Neoplasm Metastasis
  • Biliary Tract Neoplasms