NCT02182778

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

July 9, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2018

Completed
Last Updated

February 21, 2019

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

June 28, 2014

Last Update Submit

February 19, 2019

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

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

    Probability of 1-year survival (%)

Secondary Outcomes (3)

  • Response rate

    Every 3 months, up to 24 months

  • Progression free survival

    Every 3 months, up to 24 months

  • Number of Participants with Adverse Events as a Measure of Safety

    24 months

Study Arms (2)

Gemcitabine/Cisplatin group

EXPERIMENTAL

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

Drug: Gemcitabine/Cisplatin /S-1

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.

Drug: Gemcitabine/Cisplatin

Interventions

Gemcitabine/CisplatinDRUG

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

Also known as: Gemcitabine;gemzer, Cisplatin;Cispulan
Gemcitabine/Cisplatin /S-1 group
Gemcitabine/Cisplatin /S-1DRUG

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

Also known as: Gemcitabine;gemzer, Cisplatin;Cispulan S-1;TS-1,
Gemcitabine/Cisplatin group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Related Publications (2)

  • 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.

    PMID: 35900311DERIVED

  • 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.

    PMID: 25477010DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

GemcitabineCisplatinS 1 (combination)

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Masashi Kanai

    Kyoto University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2014

First Posted

July 8, 2014

Study Start

July 9, 2014

Primary Completion

February 4, 2016

Study Completion

April 16, 2018

Last Updated

February 21, 2019

Record last verified: 2018-04

Locations

JP(1)