A Phase 2 interventional study of Gemcitabine and S-1 in Biliary Tract Cancer, sponsored by Kansai Hepatobiliary Oncology Group. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-05-16.
Sponsored by Kansai Hepatobiliary Oncology Group · Phase 2, Interventional, and Treatment
To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after hemihepatectomy.
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.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's enrollment of 70 is above the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Kansai Hepatobiliary Oncology Group is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1000mg/m2, day 1 every 2 weeks
Drug: Gemcitabine
80mg/m2/day, day 1-28, every 6 weeks
Drug: S-1
1000mg/m2, day 1 every 2 weeks
Also known as: gemzer
80mg/m2/day, day 1-28, every 6 weeks
Also known as: TS-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
Time frame: One year
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
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Kansai Hepatobiliary Oncology Group