UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013430 |
|---|---|
| Receipt number | R000015680 |
| Scientific Title | A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by TS-1 for patients with resected pancreatic cancer (TOSPAC-02) |
| Date of disclosure of the study information | 2014/03/15 |
| Last modified on | 2018/03/23 01:51:34 |
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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 TS-1 for patients with resected pancreatic cancer (TOSPAC-02)
Acronym
A phase II study of portal infusion chemotherapy followed by TS-1 for resected pancreatic cancer (TOSPAC-02)
Scientific Title
A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by TS-1 for patients with resected pancreatic cancer (TOSPAC-02)
Scientific Title:Acronym
A phase II study of portal infusion chemotherapy followed by TS-1 for resected pancreatic cancer (TOSPAC-02)
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 TS-1 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 TS-1 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
55
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
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
contact@keio-hpbts.jp
Sponsor or person
Institute
Tokyo Study Group for Pancreatic Cancer (TOSPAC)
Institute
Department
Personal name
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
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
慶應義塾大学病院（東京都）、川崎市立川崎病院（神奈川県）、北里研究所病医院（東京都）、東京歯科大学市川総合病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
| 2014 | Year | 03 | Month | 15 | Day |
Last modified on
| 2018 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015680
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