UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002154
Receipt number R000002629
Scientific Title Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.
Date of disclosure of the study information 2009/07/02
Last modified on 2017/05/16 19:12:43

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.

Acronym

Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.

Scientific Title

Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.

Scientific Title:Acronym

Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.

Region

Japan


Condition

Condition

Patients with gemcitabine-refractry advanced pancreatic cancer.

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical efficacy and toxicity of 2nd line therapy against gemcitabine-refractory advanced pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Median Survival Time of 2nd line therapy

Key secondary outcomes

Clinical Benefit Response (CBR)
Safety
Time To Progression (TTP)
Overall Survival (OS)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A : Gemcitabine 1,000mg/m2 is administered with for 30-min intravenous infusion on day 1, 8 and 15 every 4 weeks.

Interventions/Control_2

Group B : Best available fluoropyrimidine therapy : Each institute can choose following available treatment therapy.
1) UFT therapy : UFT 400 mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks.
2) 5-FU therapy : 5-FU 600mg/m2 is administered with 60-min intravenous infusion on day 1, 8 and 15 every 4 weeks.
3) TS-1 therapy : TS-1 80 mg/m2/day is administered orally for 2 consecutive weeks every 3 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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed pancreatic ductal carcinoma.
2) Patients of age =>20 and 80>
3) Performance Status:0-2(ECOG)
4) Life expectancy more than 1 months.
5) Adequate organ functions.
neutrophils >=2,000/mm3
leukocytes =>4,000 and 12,000/mm3>
platelets >=100,000/mm3
hemoglobin >=9.5g/dl
AST(GOT)/ALT(GPT) <=LLN x2.5
total bilirubin <=LLN x2
serum creatinine <= LLN
BUN <= LLN
PaO2 >= 70 torr
6) Written informed consent.

Key exclusion criteria

1) Lung fibrosis or intestinal pneumoni, and anamnesis or imaging findings.
2) Severe infection.
3) Severe complication.
(heart failure, angina pectoris, arrhythmia, diabetes , intestines paralysis, ileus, myocardial infarction within 6 months after the onset.)
4) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy.
5) Watery diarrhea.
6) Jaundice.
7) Uncontrolled pleural or abdominal effusion.
8) Severe drug hypersensitivity.
9) History of other active malignancy.
10) Severe mental illness
11) Patients who are judged inappropriate for the entry into the study by the investigater.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya Ioka

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Medical Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6945-1181

Email

ioka_ta@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Ioka

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Medical Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6972-1181

Homepage URL


Email

ioka-ta@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology
Pancreatic cancer study Group

Institute

Department

Personal name



Funding Source

Organization

Osaka foundation for the prevention of cancer and cardiovascular diseases

Organization

Division

Category of Funding Organization

Non profit foundation

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

2009 Year 07 Month 02 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


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

Completed

Date of protocol fixation

2005 Year 10 Month 14 Day

Date of IRB


Anticipated trial start date

2005 Year 11 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry

2010 Year 02 Month 01 Day

Date trial data considered complete

2010 Year 12 Month 01 Day

Date analysis concluded

2011 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 07 Month 02 Day

Last modified on

2017 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002629


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name