GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer

• ClinicalTrials.gov Identifier: NCT02182778
• Recruitment Status: Completed
• First Posted: July 8, 2014
• Last Update Posted: February 21, 2019
• Sponsor: Kansai Hepatobiliary Oncology Group
• Information provided by (Responsible Party): Kansai Hepatobiliary Oncology Group

Tracking Information

• First Submitted Date: June 28, 2014
• First Posted Date: July 8, 2014
• Last Update Posted Date: February 21, 2019
• Actual Study Start Date: July 9, 2014
• Actual Primary Completion Date: February 4, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 7, 2014)

Overall survival rate [ Time Frame: Probability of 1-year survival (%) ]

The primary endpoint is designated to evaluate overall survival rate at 12-month.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 7, 2014)

• Response rate [ Time Frame: Every 3 months, up to 24 months ]
  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.
• Progression free survival [ Time Frame: Every 3 months, up to 24 months ]
  In oredr to research the progression survival, the investigators will check the presence of progression disease for each patient every three months.
• Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 24 months ]
  The investigators will examine the frequency and the degree of each side effect that will appear to the patient at each course of chemotherapy .

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Biliary Tract Cancer

Intervention

• Drug: Gemcitabine/Cisplatin
  Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
  Other Name: Gemcitabine;gemzer, Cisplatin;Cispulan
• Drug: 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 Name: Gemcitabine;gemzer, Cisplatin;Cispulan S-1;TS-1,

Study Arms

• Experimental: Gemcitabine/Cisplatin group
  Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
  Intervention: Drug: Gemcitabine/Cisplatin /S-1
• Experimental: 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.
  Intervention: Drug: Gemcitabine/Cisplatin

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 31, 2016): 246
• Original Estimated Enrollment (submitted: July 7, 2014): 220
• Actual Study Completion Date: April 16, 2018
• Actual Primary Completion Date: February 4, 2016 (Final data collection date for primary outcome measure)

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

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Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT02182778
• Other Study ID Numbers: KHBO1401; UMIN 000014371 ( Registry Identifier: UMIN )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kansai Hepatobiliary Oncology Group
• Original Responsible Party: Same as current
• Current Study Sponsor: Kansai Hepatobiliary Oncology Group
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Masashi Kanai; Kyoto University

• PRS Account: Kansai Hepatobiliary Oncology Group
• Verification Date: April 2018