UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Minoru Kitago
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	contact@keio-hpbts.jp

Public contact
Name of contact person	Minoru Kitago
Organization	Keio University School of Medicine
Division name	Department of Surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 08 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005374