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

Primary Purpose

Biliary Tract Cancer

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Gemcitabine/Cisplatin

Gemcitabine/Cisplatin /S-1

About this trial

This is an interventional treatment trial for Biliary Tract Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with cytologically or histologically proved biliary tract cancer
age >=20 years
Performance Status (PS) 0-2
No prior history of chemotherapy or radiotherapy.
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)
Adequate oral intake
Provided written informed consent -

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
-

Sites / Locations

Kyoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Gemcitabine/Cisplatin group

Gemcitabine/Cisplatin /S-1 group

Arm Description

Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.

S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.

Outcomes

Primary Outcome Measures

Overall survival rate

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

Secondary Outcome Measures

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.

Progression free survival

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

The investigators will examine the frequency and the degree of each side effect that will appear to the patient at each course of chemotherapy .

Full Information

NCT ID

NCT02182778

First Posted

June 28, 2014

Last Updated

February 19, 2019

Sponsor

Kansai Hepatobiliary Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT02182778

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

July 9, 2014 (Actual)

Primary Completion Date

February 4, 2016 (Actual)

Study Completion Date

April 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kansai Hepatobiliary Oncology Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

246 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine/Cisplatin group

Arm Type

Experimental

Arm Description

Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.

Arm Title

Gemcitabine/Cisplatin /S-1 group

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

Gemcitabine/Cisplatin

Other Intervention Name(s)

Gemcitabine;gemzer, Cisplatin;Cispulan

Intervention Description

Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine/Cisplatin /S-1

Other Intervention Name(s)

Gemcitabine;gemzer, Cisplatin;Cispulan S-1;TS-1,

Intervention Description

S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.

Primary Outcome Measure Information:

Title

Overall survival rate

Description

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

Time Frame

Probability of 1-year survival (%)

Secondary Outcome Measure Information:

Title

Response rate

Description

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.

Time Frame

Every 3 months, up to 24 months

Title

Progression free survival

Description

In oredr to research the progression survival, the investigators will check the presence of progression disease for each patient every three months.

Time Frame

Every 3 months, up to 24 months

Title

Number of Participants with Adverse Events as a Measure of Safety

Description

The investigators will examine the frequency and the degree of each side effect that will appear to the patient at each course of chemotherapy .

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with cytologically or histologically proved biliary tract cancer age >=20 years Performance Status (PS) 0-2 No prior history of chemotherapy or radiotherapy. 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) Adequate oral intake Provided written informed consent - 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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masashi Kanai

Organizational Affiliation

Kyoto University

Official's Role

Study Director

Facility Information:

Facility Name

Kyoto University Hospital

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

35900311

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.

Results Reference

derived

PubMed Identifier

25477010

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.

Results Reference

derived

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

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