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

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kansai Hepatobiliary Oncology Group
• Treatments: Cisplatin; Gemcitabine

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.