UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014805
Receipt number R000017079
Scientific Title Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer
Date of disclosure of the study information 2014/08/11
Last modified on 2017/08/30 22:40:39

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Basic information

Public title

Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer

Acronym

Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer

Scientific Title

Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer

Scientific Title:Acronym

Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer

Region

Japan


Condition

Condition

pancreatic cancer or biliary tract cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective is to evaluate the feasibility of TS-1 which is administered orally alternate day for 6 weeks for patients with unresectable pancreatic cancer or biliary tract cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Treatment completed rate

Key secondary outcomes

Overall survival
Progeression-free survival
Adverse events
Time to treatment failure


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily every monday, wednesday,friday and sunday for 6 weeks.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)unresectable or recurrent pancreatic cancer or biliary tract cancer(include locally advanced or recurence)
2)standard chemotyerapy cannot be performed for some reason
3)sufficient function of important organs
WBC: >=2,000/mm3 and <=12,000/mm3
Neut:>=1,000/mm3
Platelet: >=75,000/mm3
Hem: >=8.0g/dl
sT.bil: <=3.0mg/dl
AST, ALT: <= 150IU/L
Ccr: >=30 ml/min/body
4)oral intake
5)written informed consent
*ECOG P.S.:anything is OK

Key exclusion criteria

1)administration contraindication of TS-1
2)with clinically important infection
3)with sever heart failure
4)with interstitial pneumonia or pulmonary fibrosis
5)with sever complication(Intestinal paralysis, Ileus, uncontrollable diabetes mellitus, Renal failure, Liver failure etc)
6)massive ascites fluid or pleural effusion
7)repetitive blood infusion for gastrointestinal hemorrhage
8)with mental disorder receving treatment or needing treatment
9)administered Flucytosine, Phenytoin, Warfarin potassium
10)pregnant women or lactating women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant
11)doctor's decision not to be registered to this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Itano

Organization

Department of Surgery, Keio University School of Medicine

Division name

Department of Surgery

Zip code


Address

Shinanomachi 35, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

contact@keio-hpbts.jp


Public contact

Name of contact person

1st name
Middle name
Last name Minoru Kitago

Organization

Department of Surgery, Keio University School of Medicine

Division name

Department of Surgery

Zip code


Address

Shinanomachi 35, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL


Email

contact@keio-hpbts.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

慶応義塾大学病院(東京都)、国家公務員共済組合連合会立川病院(東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 11 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Terminated

Date of protocol fixation

2013 Year 11 Month 06 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 06 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

2014 Year 08 Month 09 Day

Last modified on

2017 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017079


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name