UMIN-CTR Clinical Trial

Basic information
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
Condition	pancreatic neoplasm
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	1-year overall survival
Key secondary outcomes	clinical benefit response (CBR), CA19-9 response, adverse events

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	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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	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）

Other administrative information
Date of disclosure of the study information	2006 Year 01 Month 19 Day

Related information
URL releasing protocol
Publication of results	Published

Result
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

Progress
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
Other related information

Management information
Registered date	2006 Year 01 Month 19 Day
Last modified on	2014 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000398

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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