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

NCT01821248 | Unknown Phase 2 DMC

• 2 other identifiers: KHBO1201UMIN000009831
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Curative resection rate

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

  14weeks

Secondary Outcomes (1)

• Response rate and toxicity

  10 weeks

Study Arms (1)

Gemcitabine, Cisplatin, S-1

EXPERIMENTAL

1000mg/m2/day1, 25mg/m2/day1, 100mg/body/day1-7

Drug: Gemcitabine, Cisplatin, S-1

Interventions

Gemcitabine, Cisplatin, S-1 DRUG

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

Also known as: Gemcitabine；gemzer, Cisplatin；Cispulan, S-1；TS-1

Gemcitabine, Cisplatin, S-1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with radiologically proven biliary tract cancer.
• No extra-hepatic disease.
• No prior therapy.
• The function of the liver is kept as satisfied after hepatectomy.
• No chronic liver damage.
• Patients of age over 20 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• 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.

You may not qualify if:

• Massive abdominal effusion requiring treatment.
• Active concomitant malignancy.
• The case suspected of infection.
• Patients with water solubility diarrhea.
• Mental disease or psychotic manifestation.
• Under continuous steroid therapy.
• Patients with acute myocardial infarction.
• Patients with severe complications.
• Pregnancy or the desire to preserve fecundity.
• Serious drug hypersensitivity or a history of drug allergy.
• Any patients judged by the investigator to be unfit to participate in the study.

Sponsors & Collaborators

• Kansai Hepatobiliary Oncology Group: lead

Study Sites (1)

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; Cisplatin; S 1 (combination)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Etsuro Hatano, MD, PhD

  Kyoto University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 29, 2013
• Study Start: July 23, 2013
• Primary Completion: September 27, 2016
• Study Completion: February 1, 2019
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

JP (1)