UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004682
Receipt number R000005490
Scientific Title Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
Date of disclosure of the study information 2010/12/10
Last modified on 2016/02/10 11:32:51

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Basic information

Public title

Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)

Acronym

Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)

Scientific Title

Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)

Scientific Title:Acronym

Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)

Region

Japan


Condition

Condition

Biliary Tract Cancer (Including intrahepatic cholangiocarcinoma)

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To decide MTD and/or RD of GEM or S-1 adjuvant therapy after hemihepatctomy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

MTD and RD

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Gemcitabine
800mg/m2 - 1000mg/m2,
day 1 every 3 weeks.
day 1, 15 every 4 weeks.
day 1, 8 every 3 weeks.
day 1, 8, 15, every 4 weeks.

Interventions/Control_2

S-1
40mg/day - 120mg/day (depend on BSA)
day 1-14, every 3 weeks
day 1-28, every 6 weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Biliary tract cancer (>= UICC Stage IB)
2) R0 or R1 resection
3) ECOG PS 0 or 1
4) No other treatment than surgery for BTC
5) Neutrophil >= 1500/uL, PLT >=100,000/uL, AST, ALT <= x5 ULN, Total Bilirubin <= x3 ULN, crtn <1.2 mg/dL
6) Oral drug intake
7) 4 - 12 weeks after the surgery
8) Written informed consent

Key exclusion criteria

1) Active double cancer
2) Severe drug allergy
3) Severe complications (IP, HF, RF, LF, ileus, DM, etc)
4) Active infections
5) Pregnancy
6) Severe mental disorder
7) Others

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Nagano

Organization

Osaka University, Graduate School of Medicine

Division name

Surgery

Zip code


Address

Yamadaoka 2-2, E2, Suita city, Osaka, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Shogo Kobayashi

Organization

Osaka University

Division name

Surgery

Zip code


Address

Yamadaoka 2-2, E2, Suita city, Osaka, JAPAN

TEL


Homepage URL


Email



Sponsor or person

Institute

Kansai Hepatobiliary Oncology Group (KHBO)

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

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


Address


Tel


Email



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

2010 Year 12 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Cancer Chemother Pharmacol. 2014 Oct;74(4):699-709

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

Main results already published

Date of protocol fixation

2010 Year 10 Month 13 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 12 Month 08 Day

Last modified on

2016 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005490


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name