UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008148
Receipt number R000009374
Scientific Title Phase I study of weekly low dose Paclitaxel for pancreato-biliary cancers after failure of gemcitabine and 5-FU
Date of disclosure of the study information 2012/06/14
Last modified on 2020/02/13 22:37:55

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Basic information

Public title

Phase I study of weekly low dose Paclitaxel for pancreato-biliary cancers after failure of gemcitabine and 5-FU

Acronym

Palliative chemotherapy with paclitaxel for pancreato-biliary cancers

Scientific Title

Phase I study of weekly low dose Paclitaxel for pancreato-biliary cancers after failure of gemcitabine and 5-FU

Scientific Title:Acronym

Palliative chemotherapy with paclitaxel for pancreato-biliary cancers

Region

Japan


Condition

Condition

pancreato-biliary cancers

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Palliative chemotherapy for pancreato-biliary cancers after failure of gemcitabine and oral S-1

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Determination of recommended dose

Key secondary outcomes

Assessment of safety, Prolonged survival after failur of S-1 and GEM, Response rate, Disease control rate, Adverse event


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

Paclitaxel

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

patient with pancreatobiliary cancer after failure of gemcitabine and 5FU.

Key exclusion criteria

Patients with a history of anti-cancer agent taxane administration.

Target sample size

9


Research contact person

Name of lead principal investigator

1st name Tetsuo
Middle name
Last name Ohta

Organization

Kanazawa University Hospital

Division name

Hepato-Biliary-Pancreatic Surgery

Zip code

920-8641

Address

13-1 Takaramachi, Kanazawa

TEL

076-265-2362

Email

hidetaji@staff.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name Hidehiro
Middle name
Last name Tajima

Organization

Kanazawa University Hospital

Division name

Hepato-Biliary-Pancreatic Surgery

Zip code

920-8641

Address

13-1 Takaramachi, Kanazawa

TEL

076-265-2362

Homepage URL


Email

hidetaji@staff.kanazawa-u.ac.jp


Sponsor or person

Institute

Kanazawa University Hospital
Hepato-Biliary-Pancreatic Surgery

Institute

Department

Personal name



Funding Source

Organization

Kanazawa University Hospital
Hepato-Biliary-Pancreatic Surgery

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

Department of Gastroenterological Surgery, Kanazawa University

Address

13-1 Takaramachi

Tel

076-265-2000

Email

hidetaji@staff.kanazawa-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

2012 Year 06 Month 14 Day


Related information

URL releasing protocol

DOI: 10.3892/mco.2017.1206 DOI: 10.3892/mco.2018.1579

Publication of results

Published


Result

URL related to results and publications

DOI: 10.3892/mco.2017.1206

Number of participants that the trial has enrolled

16

Results

BTC: PR 3, SD 2, PD 1
PDAC: SD 4, PD 6

Results date posted

2020 Year 02 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2016 Year 09 Month 07 Day

Baseline Characteristics

BTC or PDAC patients failure of GEM and 5-FU

Participant flow

See paper

Adverse events

See paper

Outcome measures

See paper

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 04 Month 01 Day

Date of IRB

2012 Year 04 Month 02 Day

Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2015 Year 12 Month 28 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 06 Month 12 Day

Last modified on

2020 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009374


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name