A phase III trial of S-1 vs. observation in patients with resected biliary tract cancer ASCOT : Adjuvant S-1 for CholangiOcarcinoma Trial (JCOG1202, ASCOT)

Conditions

Resected biliary tract cancer

Yanagimoto H, Nakachi K, Ikeda M, Konishi M, Ogawa G, Sano Y, Nomura T, Yanagibashi H, Shibuya K, Shirakawa H, Takahashi A, Sakamoto Y, Makino I, Hatano E, Gotohda N, Kamei K, Kobayashi S, Imaoka H, Ozaka M, Terashima T, Okusaka T, Furuse J, Ueno M.

2026-01-26

10.1002/jso.70135

Adjuvant S-1 vs. observation for resected biliary tract cancer: 5-year follow-up of the JCOG1202/ASCOT.

Kohei Nakachi, Masafumi Ikeda, Masaru Konishi, Junki Mizusawa, Hiroshi Katayama et al. (20 authors)

Journal of Clinical Oncology2024-06-012 citations

10.1200/jco.2024.42.16_suppl.4119

Feasibility of S-1 adjuvant chemotherapy after major hepatectomy for biliary tract cancers: An exploratory subset analysis of JCOG1202.

Kobayashi S, Nakachi K, Ikeda M, Konishi M, Ogawa G, Sugiura T, Yanagimoto H, Morinaga S, Wada H, Shimada K, Takahashi Y, Nakagohri T, Kamata K, Shimizu Y, Ajiki T, Hirano S, Gotohda N, Ueno M, Okusaka T, Furuse J.

2023-12-206 citations

10.1016/j.ejso.2023.107324

Risk factors for early relapse in patients with biliary tract cancers who underwent curative resection: An exploratory subgroup analysis of JCOG1202.

Hiroaki Yanagimoto, Kohei Nakachi, Masafumi Ikeda, Masaru Konishi, Gakuto Ogawa et al. (20 authors)

Journal of Clinical Oncology2023-01-24

10.1200/jco.2023.41.4_suppl.541

Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial.

Nakachi K, Ikeda M, Konishi M, Nomura S, Katayama H, Kataoka T, Todaka A, Yanagimoto H, Morinaga S, Kobayashi S, Shimada K, Takahashi Y, Nakagohri T, Gotoh K, Kamata K, Shimizu Y, Ueno M, Ishii H, Okusaka T, Furuse J, Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG).

2023-01-01162 citations

10.1016/s0140-6736(22)02038-4

Adjuvant S-1 versus observation in curatively resected biliary tract cancer: A phase III trial (JCOG1202: ASCOT).

Masafumi Ikeda, Kohei Nakachi, Masaru Konishi, Shogo Nomura, Hiroshi Katayama et al. (20 authors)

Journal of Clinical Oncology2022-01-1931 citations

10.1200/jco.2022.40.4_suppl.382

Feasibility of adjuvant S-1 chemotherapy after major hepatectomy for biliary tract cancers: An exploratory subset analysis of JCOG1202.

Shogo Kobayashi, Kohei Nakachi, Masafumi Ikeda, Masaru Konishi, Gakuto Ogawa et al. (20 authors)

Journal of Clinical Oncology2022-01-191 citations

10.1200/jco.2022.40.4_suppl.408

A randomized Phase III trial of adjuvant S-1 therapy vs. observation alone in resected biliary tract cancer: Japan Clinical Oncology Group Study (JCOG1202, ASCOT)

Kohei Nakachi, Masaru Konishi, Masafumi Ikeda, Junki Mizusawa, Junko Eba et al. (9 authors)

Japanese Journal of Clinical Oncology2018-02-0684 citations

10.1093/jjco/hyy004

A randomized phase III trial comparing adjuvant chemotherapy with S-1 vs. surgery alone in patients with resectable biliary tract cancer (JCOG1202: ASCOT).

Masafumi Ikeda, Kohei Nakachi, Masaru Konishi, Shuichi Mitsunaga, Junki Mizusawa et al. (15 authors)

Journal of Clinical Oncology2017-05-202 citations

10.1200/jco.2017.35.15_suppl.tps4144

Interventions

A:Surgery alone B:Surgery followed by chemotherapy with S-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed as biliary tract adenocarcinoma or adenosquamous carcinoma (carcinoma of the intrahepatic bile duct (IHBD), extrahepatic bile duct (EHBD), gallbladder (GB), or ampulla of Vater (AV)) in resected specimen. The mixed-type is eligible when adenocarcinoma or adenosquamous carcinoma is dominant. 2) Pathologically diagnosed as carcinoma of the EHBD, GB and AV : T2-4, N0, M0 or T1-4, N1, M0 or carcinoma of IHBD : T1-4, N0-1, M0 according to UICC classification 3) R0 or R1 4) Aged 20 to 80 years old 5) ECOG performance status of 0 or 1 6) No distant metastases and ascites/pleural effusion according to CT or MRI after operation 7) Patients who had undergone the following surgery with D1 or more lymphadenectomy; pancreaticoduodenectomy, hepatectomy, bile duct resection, caudal lobectomy and/or cholecystectomy 8) No previous history of chemotherapy or radiotherapy for biliary tract cancer and the other malignancies. 9) Between 2 and 10 weeks after resection 10) Adequate oral intake 11) Wound after operation is healed and surgical drain is removed. 12) No watery diarrhea 13) Adequate organ functions 14) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancy except carcinoma in situ or intramucosal tumor curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Impossible to use both iodine and gadolinium due to being allergic to contrast agent 4) Fever of 38 degrees Celsius or over 5) Pregnant or lactating women or women of childbearing potential, male expecting partner's pregnancy 6) Severe psychiatric disease 7) Poorly controlled diabetes mellitus 8) Poorly controlled hypertension 9) Unstable angina pectoris within 3 weeks or with a history of myocardial infarction within 6 months 10) Patients requiring flucytosine, phenytoin or warfarin 11) Interstitial pneumonia, pulmonary fibrosis or severe emphysema

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Relapse-free survival, Adverse events, Proporion of treatment completion, Serious adverse events	—

Countries

Japan

Contacts

Public ContactMasafumi Ikeda, Kohei Nakachi

JCOG1202 Coordinating Office National Cancer Center Hospital East, Kashiwa Hepatobiliary and Pancreatic Medical Oncology

JCOG_sir@ml.jcog.jp(+81)4-7133-1111

Outcome results

None listed