JRCT ID: jRCTs051180178
Registered date:26/03/2019
Gemicitabine/Cisplatin/nab-paclitaxel for biliary tract cancers (GCA in BTC)
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Biliary tract cancer |
Date of first enrollment | 12/02/2018 |
Target sample size | 20 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | gemcitabine 600, 800, 1000 mg/m2 cisplatin 25 mg/m2 nab-PTX 80, 100, 125 mg/m2 day 1 and8, every 3 weeks 2 cycles. |
Outcome(s)
Primary Outcome | Phase I: Feasibilty (MTD and RD) Phase II: Response rate, Tumor control rate, Resectability and R0 resection rate |
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Secondary Outcome | Histological effect, safety, completion rate, PFS, OS, 1-year and 2-year OS, 1-year and 2-year PFS, site of progression |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1) age> 20. 2) PS 0-1 3) no impairment of bone marrow, liver, renal, cardiac, and pulmonary function: 3-a) neutrophil >= 2000/mm3 3-b) platelet >= 100,000/mm3 3-c) hemoglobin >= 9.0 g/dL 3-d) bilirubin <= 2.0 mg/dL 3-e) AST, ALT <= 5 x UNL 3-f) creatinine <= 1.5 mg/dL 4) written informed consent |
Exclude criteria | 1) distant metastasis 2) estimated remnant liver volume after PTPE would become under 35% because the measurement includes resectability 3) active cancers, without carcinoma in situ 4) suspected or definitive pulmonary fibrosis or interstitial pneumonia 5) watery diarrhea 6) active infection without viral hepatitis nor cholangitis 7) severe complications: cardiac, renal, liver failure, bleeding peptic ulcer, bowel paralysis, bowel obstruction, uncontrollable diabetes mellitus 8) pregnancy 9) severe mental disorder 10) severe allergy 11) entry on other studies 12) inappropriate by the investigators |
Related Information
Primary Sponsor | Kobayashi Shogo |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000029490 |
Contact
Public contact | |
Name | Shogo Kobayashi |
Address | 2-15, Yamadaoka, Suita, Osaka 565-0871, Japan Osaka Japan 565-0871 |
Telephone | +81-6-6879-3251 |
s-kobayashi@umin.ac.jp | |
Affiliation | Osaka University Hospital |
Scientific contact | |
Name | Shogo Kobayashi |
Address | 2-15, Yamadaoka, SUita, Osaka 565-0871, JAPAN Osaka Japan 565-0871 |
Telephone | +81-6-6879-3251 |
s-kobayashi@umin.ac.jp | |
Affiliation | Osaka University Hospital |