UMIN-CTR Clinical Trial

Public title

Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506)

Acronym

Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506)

Scientific Title

Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506)

Scientific Title:Acronym

Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506)

Region

Japan

Condition

pancreatic neoplasm

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to evaluate safety and efficacy of a gemicitabin alone as a first-line treatment for locally advanced pancreatic cancer patients.
We plan a next phase III study to compare this regimen with chemoradiotherapy with fluorouracil.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

1-year overall survival

Key secondary outcomes

clinical benefit response (CBR), CA19-9 response, adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients receive 30-minute infusion of gemcitabine (1000 mg/m2/day, days 1, 8, and 15) every 4 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients are included if they meet the following criteria: histologically or cytologically proven exocrine pancreatic cancer, locally advanced: T4 (UICC) without obvious organ metastasis, aged 20 years or over, definitive chemoradiotherapy can be indicated: all pancreas lesions and lymph node metastases are included in the radiation field, 15 cm on a side, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. In recurred cases, sufficient organ function. They have no history of radiotherapy, chemotherapy and surgery for pancreas except for exploraratory laparotomy, choledochojejunostomy and gastrojejunostomy. They provided written informed consent.

Key exclusion criteria

Patients are excluded if they meet the following criteria: They have obvious ascetic or pleural effusion, lung fibrosis or pneumonitis, uncontrolled diabetes mellitus in spite of using more than 40 unit insulin, Classification of New York Heart Association (NYHA) of III or IV, myocardial infarction within 6 months before this trial, synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, or severe mental disease.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Junzi Furuse, MD, PhD

Organization

Kyorin University School of Medicine

Division name

Medical Oncology Division

Zip code

Address

6-20-2,Shinkawa,Mitaka,Tokyo 181-8611,Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Hiroshi Ishiii, MD, PhD

Organization

JCOG0506 Coordinating Office

Division name

Medical Oncology Division, National Cancer Institute Hospital

Zip code

Address

63-10-6,Ariake,Koto-ku,Tokyo 135-8550,Japan

TEL

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

北海道大学病院 (北海道）
岩手県立中央病院（岩手県）
山形県立中央病院（山形県）
茨城県立中央病院・茨城県地域がんセンター（茨城県）
栃木県立がんセンター（栃木県）
埼玉県立がんセンター（埼玉県）
国立がんセンター東病院 （千葉県）
総合病院国保旭中央病院 （千葉県）
国立がんセンター中央病院（東京都）
昭和大学病院（東京都）
神奈川県立がんセンター（神奈川県）
横浜市立市民病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
大阪市立総合医療センター（大阪府）
大阪医科大学（大阪府）
神戸大学医学部（兵庫県）
兵庫県立がんセンター（兵庫県）
国立病院機構四国がんセンター（愛媛県）
高知医療センター（高知県）

Date of disclosure of the study information

2006

Year

01

Month

19

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/20185458

Number of participants that the trial has enrolled

Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

2005

Year

12

Month

15

Day

Date of IRB

Anticipated trial start date

2006

Year

01

Month

01

Day

Last follow-up date

2008

Year

02

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2006

Year

01

Month

19

Day

Last modified on

2014

Year

02

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000398