UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001294
Receipt number R000001564
Scientific Title Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer
Date of disclosure of the study information 2008/08/08
Last modified on 2015/11/25 17:41:03

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Basic information

Public title

Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer

Acronym

Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer

Scientific Title

Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer

Scientific Title:Acronym

Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer

Region

Japan


Condition

Condition

Biriary tract cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Feasibility

Key secondary outcomes

Efficacy


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of gemcitabine and cisplatin for adjuvant chemotherapy

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Histologically proven biliary tract cancer after surgical resection
Stage IB,IIA, IIB,III (UICC)
R0 and R1
No previous chemo- or radiotherapy within 3 years
Within 8 weeks after operation
PS 0 and 1
Hb >=10g/dl
WBC >=3000/mm3
Neutrophil >=1500/mm3
Platelet >=100,000/mm3
AST, ALT <=150U/L
T-Bil <=3mg/dl
CCr >=45ml/min

Key exclusion criteria

Apparent infection
Fever
Heart disease
Interstitial pneumonia, pulmonary fibrosis
Other active cancers
Brain metastasis
Pericardial effusion
Allergy of the drugs
Pregnancy or patient's hope to be pregnant

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takehide Asano

Organization

National Hospital Organization Chiba-East-Hospital

Division name

Department of Surgery

Zip code


Address

673 Nitona, Chuo-ku, Chiba, Japan

TEL

043-261-5171

Email

asano@cehpnet.com


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Kainuma

Organization

Chiba Cancer Center

Division name

Gastroenterological Surgery

Zip code


Address

666-2 Nitona, Chuo-ku, Chiba, Japan

TEL

043-264-5431

Homepage URL


Email

okainuma@chiba-cc.jp


Sponsor or person

Institute

Chiba Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

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

帝京大学病院(東京都)、千葉県がんセンター(千葉県)、東海大学病院(神奈川県)、千葉東病院(千葉県)


Other administrative information

Date of disclosure of the study information

2008 Year 08 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1868-6982

Number of participants that the trial has enrolled


Results

Among 29 evaluable patients, the protocol was completed in 21 (72%) patients. Relative dose intensity (RDI) of gemcitabine and CDDP was 77% and 81%, respectively. There was no difference in the completion rate and the RDI between patients who underwent resection with vs. without major hepatectomy. Grade 3-4 toxicities included leukopenia
(14%) and neutropenia (27%). Two-year RFS and 2-year OS was 59% and 90%, respectively.

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

Completed

Date of protocol fixation

2007 Year 12 Month 13 Day

Date of IRB


Anticipated trial start date

2008 Year 01 Month 01 Day

Last follow-up date

2014 Year 10 Month 31 Day

Date of closure to data entry

2014 Year 11 Month 30 Day

Date trial data considered complete

2014 Year 11 Month 30 Day

Date analysis concluded

2014 Year 12 Month 28 Day


Other

Other related information



Management information

Registered date

2008 Year 08 Month 04 Day

Last modified on

2015 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001564


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name