Clinical trial NCT02182778: GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer
Official title: Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Biliary Tract Cancer
Lead sponsor: Kansai Hepatobiliary Oncology Group
Sponsor class: NETWORK
First posted: 2014-07-08
Enrollment: 246
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.

Detailed description: Gemcitabine/cisplatin combination therapy (GC) has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). Investigators have evaluated the efficacy and safety of gemcitabine/cisplatin/S-1 combination therapy (GCS) for patients with advanced BTC and observed the promising efficacy. In this randomized phase Ⅲ study, investigators aimed to compare GCS with GC in patients with advanced BTC.

Eligibility criteria: Inclusion Criteria:

1. Patients with cytologically or histologically proved biliary tract cancer
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:

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

   -

Primary outcomes:
measure: Overall survival rate
timeFrame: Probability of 1-year survival (%)
Secondary outcomes:
measure: Response rate
timeFrame: Every 3 months, up to 24 months
measure: Progression free survival
timeFrame: Every 3 months, up to 24 months
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 24 months
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
affiliation: Kyoto University
name: Masashi Kanai
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.