Unique ID issued by UMIN | UMIN000014371 |
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Receipt number | R000016723 |
Scientific Title | Randomized Phase III trial comparing GEM/CDDP/S-1 with GEM/CDDP for unresectable biliary tract cancer (KHBO1401) |
Date of disclosure of the study information | 2014/06/25 |
Last modified on | 2020/01/27 18:59:41 |
Randomized Phase III trial comparing GEM/CDDP/S-1 with GEM/CDDP for unresectable biliary tract cancer (KHBO1401)
GEM/CDDP/S-1 vs GEM/CDDP for biliary tract cancer (KHBO1401)
Randomized Phase III trial comparing GEM/CDDP/S-1 with GEM/CDDP for unresectable biliary tract cancer (KHBO1401)
GEM/CDDP/S-1 vs GEM/CDDP for biliary tract cancer (KHBO1401)
Japan |
unresectable biliary tract cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To validate the superiority of GEM/CDDP/S-1 over GEM/CDDP for unresectable biliary tract cancer
Efficacy
overall survival
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
GEM/CDDP/S-1 (intervention)
GEM/CDDP (control)
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with cytologically or histologically proved biliary tract cancer
2. age >=20 years
3. PS 0-2
4. No prior history of chemotherapy or radiotherapy.
5. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count >=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and renal function (creatinine clearance >=45 mL/min)
6.Adequate oral intake
7.Provided written informed consent
1. Patients with interstitial pneumonia or pulmonary fibrosis
2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months
3. Patients with severe active infection
4. Patients with moderate or marked pleural effusion or ascites necessitating drainage
5. Patients with a history of severe drug allergy
6. Patients with other serious comorbid disease
7. Patients who are pregnant or lactating, or have an intention to get pregnant
8. Patients with mental disease
9. Patients who are judged inappropriate for the entry into the study by the principle doctor
220
1st name | |
Middle name | |
Last name | MASASHI KANAI |
Kyoto University Hospital
Department of Clinical Oncology and Pharmacogenomics
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
075-751-4349
kanai@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | MASASHI KANAI |
Kyoto University Hospital
Department of Clinical Oncology and Pharmacogenomics
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
075-751-4349
kanai@kuhp.kyoto-u.ac.jp
Kansai Hepatobiliary Oncology Group
Osaka Medical Center for Cancer and Cardiovascular Diseases
Other
NO
2014 | Year | 06 | Month | 25 | Day |
Published
Main results already published
2014 | Year | 06 | Month | 24 | Day |
2014 | Year | 06 | Month | 24 | Day |
2014 | Year | 06 | Month | 24 | Day |
2019 | Year | 04 | Month | 16 | Day |
2019 | Year | 04 | Month | 16 | Day |
2014 | Year | 06 | Month | 24 | Day |
2020 | Year | 01 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016723
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