UMIN-CTR Clinical Trial

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

metastatic pancreatic adenocarcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

response rate

Key secondary outcomes

progression-free survival
overall survival
adverse events
serious adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)

Institute

Department

Personal name

Organization

Pharma Valley Center, the Shizuoka Organization for Creation Industries

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2011

Year

01

Month

26

Day

URL releasing protocol

Publication of results

Published

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

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 related 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