Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

NCT01815307 | Completed Phase 2 DMC

• 2 other identifiers: KHBO1208UMIN000009945
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after hemihepatectomy.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• 1 year recurrent free survival rate

  Duration: From randomization to evidenced recurrence or death. Rate: Number of patients with evidenced recurrence or death / number of total patients. 1 year recurrent free survival rate: recurrent free survival rate at one-year from the randomization

  One year

Secondary Outcomes (8)

• Two-year recurrent free survival rate

  Two years

• One-year overall survival rate

  One year

• Two-year overall survival rate

  Two years

• Completion rate of the protocol treatment

  6 months

• Dose intensity of anti-tumor drugs

  6 months

Study Arms (2)

Gemcitabine group

EXPERIMENTAL

1000mg/m2, day 1 every 2 weeks

Drug: Gemcitabine

S-1 group

EXPERIMENTAL

80mg/m2/day, day 1-28, every 6 weeks

Drug: S-1

Interventions

Gemcitabine DRUG

1000mg/m2, day 1 every 2 weeks

Also known as: gemzer

Gemcitabine group

S-1 DRUG

80mg/m2/day, day 1-28, every 6 weeks

Also known as: TS-1

S-1 group

Eligibility Criteria

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

You may qualify if:

• Biliary tract cancer (BTC) (\>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma
• R0 or R1 resection
• no obvious recurrent lesion
• years old or more
• Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1
• The patient underwent no other treatment than surgery for BTC
• Neutrophil must be over 1500/μl, Hemoglobin must be over 9.0g/dL, platelet must be over 100,000/μl, Aspartate transaminase (AST) and Alanine aminotransferase (ALT) must be less than 150 IU/L, total bilirubin must be less than 1.5 mg/dL, Creatinine must be less than 1.2 mg/dl, and Creatinine clearance must be over 60 mL/min
• The patient can intake drugs per os.
• From 4 to 12 weeks after the surgery
• Written informed consent

You may not qualify if:

• Existence of active double cancer
• The patient suffered from severe drug allergy
• Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
• Any active infections exist.
• Pregnancy
• Severe mental disorder
• Others

Sponsors & Collaborators

• Kansai Hepatobiliary Oncology Group: lead

Study Sites (1)

Osaka University, Graduate School of Medicine

Osaka, 565-0871, Japan

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; S 1 (combination); titanium silicide

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

Study Officials

• Hiroaki Nagano, MD, PhD

  Osaka University Graduate School of Medicine

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 21, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2017
• Last Updated: May 16, 2018

Record last verified: 2017-09

Locations

JP (1)