UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030980
Receipt number R000035372
Scientific Title Multidisciplinary treatment of cholangiocarcinoma -impact of induction chemotherapy followed by surgery-
Date of disclosure of the study information 2018/01/24
Last modified on 2021/01/26 09:43:20

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Basic information

Public title

Multidisciplinary treatment of cholangiocarcinoma
-impact of induction chemotherapy followed by surgery-

Acronym

Multidisciplinary treatment of cholangiocarcinoma

Scientific Title

Multidisciplinary treatment of cholangiocarcinoma
-impact of induction chemotherapy followed by surgery-

Scientific Title:Acronym

Multidisciplinary treatment of cholangiocarcinoma

Region

Japan


Condition

Condition

cholangiocarcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims to clarify the outcome and future issues of neoadjuvand treatment, using Gemcitabine plus TS-1 (GS), followed by curative-intent operation for cholangicarcinoma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

overall survival: OS

Key secondary outcomes

progression free survival, safety evaluation, pathological effects of neoadjuvant treatment


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

two cycles of chemotherapy with gemcitabine (800 mg/m2 on days 7 and 21) plus S-1 (80 mg/body daily on days 1 to 21 every 4 weeks), followed by surgery

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1) cholangiocarcinoma as following: (1) main, bilateral, or contralateral portal vein and/or hepatic artery invasion with or without possible vascular reconstruction; or (2) invasion of the right side of the umbilical portion (U portion) and the left side of the origin of the right posterior portal vein (P portion); or (3) regional lymph node metastasis.
2) Performance Status (ECOG):0 or 1
3) Patient's agreement to this study

Key exclusion criteria

1) patients with allergic reaction for TS-1 and gemecitabine
2) patients with severe hepatic disorder (AST or AL: 3 times of normal range or more)
3) patients with severe repeated cholangitis
4) Patients found to be wanting by principal investigators

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Shuji
Middle name
Last name Isaji

Organization

Mie University school of medicine

Division name

Hepatobiliary Pancreatic and Transplant Surgery

Zip code

5148507

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

059-232-1111

Email

isaji-s@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name Naohisa
Middle name
Last name Kuriyama

Organization

Mie University school of medicine

Division name

Hepatobiliary Pancreatic and Transplant Surgery

Zip code

5148507

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

059-232-1111

Homepage URL


Email

naokun@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University

Institute

Department

Personal name



Funding Source

Organization

other

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Clinical Research Ethics Review Committee of Mie University Hospital

Address

2-174 Edobashi, Tsu, Mie, Japan

Tel

059-232-1111

Email

kk-sien@mo.medic.mie-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 24 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

143

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2011 Year 01 Month 01 Day

Date of IRB

2016 Year 03 Month 30 Day

Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 24 Day

Last modified on

2021 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035372


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name