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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815307
• Other study ID #: KHBO1208
• Secondary ID: UMIN000009945
• Status: Completed
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: Kansai Hepatobiliary Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day 1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. Formerly, the investigators planned the study to decide more safety adjuvant protocol (recommend dose: RD) for Gemcitabine or S-1 after hemihepatectomy using Continuous Reassessment Method (CRM) analysis and decided the recommend doses. Note: In the former study, the investigators decided that tolerable ratio of Dose Limiting Toxicity (DLT) would be less than 10%.

Herein, the investigators planned the study to evaluate efficacy (recurrent free survival as primary outcome, and overall-survival as secondary outcome) and safety (as secondary outcome) in our recommended protocols, and to compare the efficacy as randomized control trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Biliary tract cancer (BTC) (>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma

2. R0 or R1 resection

3. no obvious recurrent lesion

4. 20 years old or more

5. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1

6. The patient underwent no other treatment than surgery for BTC

7. 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

8. The patient can intake drugs per os.

9. From 4 to 12 weeks after the surgery

10. Written informed consent

Exclusion Criteria:

1. Existence of active double cancer

2. The patient suffered from severe drug allergy

3. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)

4. Any active infections exist.

5. Pregnancy

6. Severe mental disorder

7. Others

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• Gemcitabine
1000mg/m2, day 1 every 2 weeks
• S-1
80mg/m2/day, day 1-28, every 6 weeks

Locations

Country	Name	City	State
Japan	Osaka University, Graduate School of Medicine	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kansai Hepatobiliary Oncology Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Two-year recurrent free survival rate		Two years
Secondary	One-year overall survival rate		One year
Secondary	Two-year overall survival rate		Two years
Secondary	Completion rate of the protocol treatment		6 months
Secondary	Dose intensity of anti-tumor drugs		6 months
Secondary	Rate and grade of adverse events or adverse drug reactions		6 months
Secondary	Duration of recurrent free survival		an expected average of 2 years
Secondary	Duration of overall survival		an expected average of 3 years