Overview

This trial is active, not recruiting.

Condition biliary tract cancer
Treatments gemcitabine, s-1
Phase phase 2
Sponsor Kansai Hepatobiliary Oncology Group
Start date January 2013
End date May 2016
Trial size 70 participants
Trial identifier NCT01815307, KHBO1208, UMIN000009945

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1000mg/m2, day 1 every 2 weeks
gemcitabine gemzer
1000mg/m2, day 1 every 2 weeks
(Experimental)
80mg/m2/day, day 1-28, every 6 weeks
s-1 TS-1
80mg/m2/day, day 1-28, every 6 weeks

Primary Outcomes

Measure
1 year recurrent free survival rate
time frame: One year

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Randomized Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Kansai Hepatobiliary Oncology Group.