Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805)

Conditions

biliary tract neoplasm

Tatsuya Okuno, Chigusa Morizane, Takuji Okusaka, Junki Mizusawa, Tomoko Kataoka et al. (20 authors)

Journal of Clinical Oncology2022-01-19

10.1200/jco.2022.40.4_suppl.419

Comparison of gemcitabine-based chemotherapies for advanced biliary tract cancers by renal function: an exploratory analysis of JCOG1113.

Ueno M, Morizane C, Okusaka T, Mizusawa J, Kataoka T, Ikeda M, Ozaka M, Okano N, Sugimori K, Todaka A, Shimizu S, Mizuno N, Yamamoto T, Sano K, Tobimatsu K, Katanuma A, Miyamoto A, Yamaguchi H, Nishina T, Shirakawa H, Kojima Y, Oono T, Kawamoto Y, Furukawa M, Iwai T, Sudo K, Miyakawa H, Yamashita T, Yasuda I, Takahashi H, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J, members of the Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG)..

2021-06-182 citations

10.1038/s41598-021-92166-3

The influence of renal function on gemcitabine-based chemotherapy for advanced biliary tract cancer: An exploratory subgroup analysis of JCOG1113.

Makoto Ueno, Chigusa Morizane, Takuji Okusaka, Gakuto Ogawa, Yuya Sato et al. (20 authors)

Journal of Clinical Oncology2019-01-29

10.1200/jco.2019.37.4_suppl.368

Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer: A Japan Clinical Oncology Group study (JCOG1113, FUGA-BT).

Chigusa Morizane, Takuji Okusaka, Junki Mizusawa, Hiroshi Katayama, Makoto Ueno et al. (20 authors)

Journal of Clinical Oncology2018-02-0124 citations

10.1200/jco.2018.36.4_suppl.205

Interventions

A: Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S-1(60-100 mg/day, day1-14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer 2) Recurrent or unrespectable biliary tract cancer 3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma 4) Without CNS metastasis 5) Without moderate or more ascites/pleural effusion 6) No previous therapy against biliary tract cancer 7) No previous chemotherapy or radiotherapy against any other malignancies 8) ECOG PS of 0 or 1 9) Sufficient oral intake 10) Aged 20 to 79 years old 11) Adequate organ functions 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis 4) Patients requiring systemic steroids medication 5) Interstitial pneumonia or fibroid lung 6) Watery diarrhea 7) Active bacterial or fungous infection 8) Severe complication 9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 10) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy

Design outcomes

Primary

Measure	Time frame
overall survival (1-year survival)	—

Secondary

Measure	Time frame
progression-free survival, response rate, adverse events, severe adverse events	—

Countries

Japan

Contacts

Public ContactChigusa Morizane

JCOG0805 Coordinating Office Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp03-3542-2511

Outcome results

None listed