UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004958
Receipt number R000005899
Scientific Title Phase II study of S-1 plus Leucovorin for metastatic pancreatic adenocarcinoma (JASPAC 03)
Date of disclosure of the study information 2011/01/26
Last modified on 2015/03/30 15:20:28

* 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

Phase II study of S-1 plus Leucovorin for metastatic pancreatic adenocarcinoma (JASPAC 03)

Acronym

Phase II study of S-1 plus Leucovorin for metastatic pancreatic adenocarcinoma (JASPAC 03)

Scientific Title

Phase II study of S-1 plus Leucovorin for metastatic pancreatic adenocarcinoma (JASPAC 03)

Scientific Title:Acronym

Phase II study of S-1 plus Leucovorin for metastatic pancreatic adenocarcinoma (JASPAC 03)

Region

Japan


Condition

Condition

metastatic pancreatic adenocarcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of S-1 plus Leucovorin for patients with metastatic pancreatic adenocarcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

response rate

Key secondary outcomes

progression-free survival
overall survival
adverse events
serious adverse events


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

S-1(40~60mg)+LV(25mg) orally twice daily for 1 week, followed by 1-week rest

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Diagnosed as invasive ductal adenocarcinoma by enhanced abdominal CT
or overall observation
2) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma or adenosquamous carcinoma by the biopsy or cytology of pancreatic tumor or metastatic sites
3) Metastatic pancreatic adenocarcinoma with mesurable lesion according to Response evaluation criteria in solid tumors (RECIST) guideline version 1.1
4) Without CNS metastasis
5) Without moderate or more ascites/pleural effusion
6) Aged 20 to 75 years old
7) ECOG PS of 0 or 1
8) No previous therapy for pancreatic adenocarcinoma, except for a recurrence after 6 months since the end of adjuvant chemotherapy with gemcitabine
9)No previous chemotherapy or radiotherapy against any other malignancies
10) Sufficient oral intake
11)Adequate organ functions
12)Written informed consent

Key exclusion criteria

1) Required to continue to take flucytosine, phenytoin, and warfarin
2) Active infections
3) High fever(over 38 degrees)
4) Severe complications (heart failure, myocardial infarction, renal failure, liver cirrhosis, ileus, interstitial lung disease, uncontrolled diabetes, cerebrovascular disorder, severe mental disorder, and so on)
5)Uncontrollable watery diarrhea or severe bowel disorder
6) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
7) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant
8) Patients requiring systemic steroids medication
9) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy
10) Inadequate physical condition, as diagnosed by primary physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Fukutomi

Organization

Shizuoka Cancer Center

Division name

Division of GI Oncology

Zip code


Address

1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Akiko Todaka

Organization

JASPAC03 Coordinating Office

Division name

Shizuoka Cancer Center, Division of GI Oncology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)

Institute

Department

Personal name



Funding Source

Organization

Pharma Valley Center, the Shizuoka Organization for Creation Industries

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

杏林大学医学部付属病院(東京都)
神戸大学医学部附属病院(兵庫県)
国立がん研究センター中央病院(東京都)
国立がん研究センター東病院(千葉県)
国立病院機構大阪医療センター(大阪府)
埼玉県立がんセンター(埼玉県)
癌研究会有明病院(東京都)
静岡県立静岡がんセンター(静岡県)
聖マリアンナ医科大学病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2011 Year 01 Month 26 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


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

2011 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2011 Year 02 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

2011 Year 01 Month 26 Day

Last modified on

2015 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005899


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name