GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer
NCT ID: NCT02182778
Last Updated: 2019-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
246 participants
INTERVENTIONAL
2014-07-09
2018-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemcitabine/Cisplatin group
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
Gemcitabine/Cisplatin /S-1
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
Gemcitabine/Cisplatin /S-1 group
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
Gemcitabine/Cisplatin
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
Interventions
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Gemcitabine/Cisplatin
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
Gemcitabine/Cisplatin /S-1
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. age \>=20 years
3. Performance Status (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 -
Exclusion Criteria
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
\-
20 Years
ALL
No
Sponsors
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Kansai Hepatobiliary Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Masashi Kanai
Role: STUDY_DIRECTOR
Kyoto University
Locations
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Kyoto University Hospital
Kyoto, , Japan
Countries
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References
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Ioka T, Kanai M, Kobayashi S, Sakai D, Eguchi H, Baba H, Seo S, Taketomi A, Takayama T, Yamaue H, Takahashi M, Sho M, Kamei K, Fujimoto J, Toyoda M, Shimizu J, Goto T, Shindo Y, Yoshimura K, Hatano E, Nagano H; Kansai Hepatobiliary Oncology Group (KHBO). Randomized phase III study of gemcitabine, cisplatin plus S-1 versus gemcitabine, cisplatin for advanced biliary tract cancer (KHBO1401- MITSUBA). J Hepatobiliary Pancreat Sci. 2023 Jan;30(1):102-110. doi: 10.1002/jhbp.1219. Epub 2022 Aug 9.
Kanai M, Hatano E, Kobayashi S, Fujiwara Y, Marubashi S, Miyamoto A, Shiomi H, Kubo S, Ikuta S, Yanagimoto H, Terajima H, Ikoma H, Sakai D, Kodama Y, Seo S, Morita S, Ajiki T, Nagano H, Ioka T. A multi-institution phase II study of gemcitabine/cisplatin/S-1 (GCS) combination chemotherapy for patients with advanced biliary tract cancer (KHBO 1002). Cancer Chemother Pharmacol. 2015 Feb;75(2):293-300. doi: 10.1007/s00280-014-2648-9. Epub 2014 Dec 5.
Other Identifiers
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UMIN 000014371
Identifier Type: REGISTRY
Identifier Source: secondary_id
KHBO1401
Identifier Type: -
Identifier Source: org_study_id
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