A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer (BTC) With Node Metastasis

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Brief Title

A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer (BTC) With Node Metastasis

Official Title

A Multicenter Phase II Trial of Preoperative Chemotherapy With Gemcitabine/ Cisplatin /S-1 (GCS) for Biliary Tract Cancers With Lymph Node Metastasis Diagnosed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)

Brief Summary

      To evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine/
      Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET.
    

Detailed Description

      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 Advanced Biliary tract Cancer (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 Median Survival Time (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 preoperative
      chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node
      metastasis by FDG-PET
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Curative resection rate

Secondary Outcome

 Response rate and toxicity

Condition

Biliary Tract Cancer

Intervention

Gemcitabine, Cisplatin, S-1

Study Arms / Comparison Groups

 Gemcitabine, Cisplatin, S-1
Description:  1000mg/m2/day1, 25mg/m2/day1, 100mg/body/day1-7

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

July 23, 2013

Completion Date

February 2019

Primary Completion Date

September 27, 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with radiologically proven biliary tract cancer.

          2. No extra-hepatic 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. Eastern Cooperative Oncology Group (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, Aspartate transaminase (AST)/alanine
             aminotransferase (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.
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Etsuro Hatano, MD, PhD, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01821248

Organization ID

KHBO1201

Secondary IDs

UMIN000009831

Responsible Party

Sponsor

Study Sponsor

Kansai Hepatobiliary Oncology Group


Study Sponsor

Etsuro Hatano, MD, PhD, Study Director, Kyoto University


Verification Date

February 2019