Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UMIN 000014371 | Registry Identifier | UMIN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.
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 â…¢ study, investigators aimed to compare GCS with GC in patients with advanced BTC.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine/Cisplatin group | Experimental | Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks. |
|
| Gemcitabine/Cisplatin /S-1 group | Experimental | S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine/Cisplatin | Drug | Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | The primary endpoint is designated to evaluate overall survival rate at 12-month. | Probability of 1-year survival (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | The investigators will conduct CT test every 3 months in order to measure the tumor size of each patient and evaluate the best tumor response according to RECIST criteria. | Every 3 months, up to 24 months |
| Progression free survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with interstitial pneumonia or pulmonary fibrosis
Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months
Patients with severe active infection
Patients with moderate or marked pleural effusion or ascites necessitating drainage
Patients with a history of severe drug allergy
Patients with other serious comorbid disease
Patients who are pregnant or lactating, or have an intention to get pregnant
Patients with mental disease
Patients who are judged inappropriate for the entry into the study by the principle doctor
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Masashi Kanai | Kyoto University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35900311 | Derived | 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. | |
| 25477010 |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 16, 2022 | |
| Reset | Jul 13, 2023 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 16, 2022 | Jul 13, 2023 |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine/Cisplatin /S-1 | Drug | S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks. |
|
|
In oredr to research the progression survival, the investigators will check the presence of progression disease for each patient every three months.
| Every 3 months, up to 24 months |
| Number of Participants with Adverse Events as a Measure of Safety | The investigators will examine the frequency and the degree of each side effect that will appear to the patient at each course of chemotherapy . | 24 months |
| Derived |
| 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. |
| D004066 |
| Digestive System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |