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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004504
Receipt No. R000005374
Scientific Title A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with resected pancreatic cancer (TOSPAC-01)
Date of disclosure of the study information 2010/11/15
Last modified on 2016/05/09

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Basic information
Public title A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with resected pancreatic cancer (TOSPAC-01)
Acronym A phase II study of portal infusion chemotherapy followed by gemcitabine for resected pancreatic cancer (TOSPAC-01)
Scientific Title A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with resected pancreatic cancer (TOSPAC-01)
Scientific Title:Acronym A phase II study of portal infusion chemotherapy followed by gemcitabine for resected pancreatic cancer (TOSPAC-01)
Region
Japan

Condition
Condition Resected pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility and efficacy of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with pancratic cancer after surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease free survival
Incidence of severe adverse events
Key secondary outcomes Overall survival
Incidence of adverse events
Proportion of treatment completion

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 With adjuvant chemotherapy of 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine after surgery
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven invasive ductal carcinoma of the pancreas
2) Macroscopically curative resection (R0, R1)
3) No history of prior chemotherapy or radiotherapy for pancreatic cancer except pancreatectomy
4) ECOG PS: 0-1
5) Sufficient organ functions before surgery
WBC > 4,000/mm3
Neutrophil > 2,000/mm3
Plt > 100,000/mm3
Hb > 9 g/dl
AST, ALT < 5 times the upper limit of the normal range
Serum creatinine < the upper limit of the normal range
6) Placement of the catheter for portal infusion chemotherapy within the portal vein
7) Written informed consent
Key exclusion criteria 1) Pulmonary fibrosis or interstitial pneumonia
2) Uncontrolled pleural effusion
3) Resection of the distant organ metastasis
4) Active double cancer
5) Active infection
6) History of serious complications related to surgery
7) Active peptic ulcer
8) History of myocardial infarction within three months
9) Severe mental disorder
10) Pregnant or breast feeding
11) Patients judged inappropriate for the study by the physicians
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Kitago
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email contact@keio-hpbts.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Kitago
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email contact@keio-hpbts.jp

Sponsor
Institute Tokyo Study Group for Pancreatic Cancer (TOSPAC)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 11 Month 15 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 No longer recruiting
Date of protocol fixation
2010 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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
2010 Year 11 Month 04 Day
Last modified on
2016 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005374

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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