NCT01821248

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

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Kansai Hepatobiliary Oncology Group · Network
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine, Cisplatin, S-1	Preoperative chemotherapy (GCS) 3 cycles -FDG-PET- surgery GCS therapy Gemcitabine 1000mg/m2/day1 Cisplatin 25mg/m2/day1 S-1 100mg/body/day1-7

Timeline

• Start date: 2013-07-23
• Primary completion: 2016-09-27
• Completion: 2019-02-01
• First posted: 2013-03-29
• Last updated: 2019-02-21

Locations

1 site across 1 country: Japan