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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002176
Receipt No. R000002597
Scientific Title A clinical phase-II trial of neoadjuvant chemoradiation therapy using S-1 for locally advanced pancreatic cancer (PerSeUS-GP-01)
Date of disclosure of the study information 2009/08/01
Last modified on 2019/03/12

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Basic information
Public title A clinical phase-II trial of neoadjuvant chemoradiation therapy using S-1 for locally advanced pancreatic cancer (PerSeUS-GP-01)
Acronym Radiation therapy with S-1 for locally advanced pancreatic cancer (PerSeUS-GP-01)
Scientific Title A clinical phase-II trial of neoadjuvant chemoradiation therapy using S-1 for locally advanced pancreatic cancer (PerSeUS-GP-01)
Scientific Title:Acronym Radiation therapy with S-1 for locally advanced pancreatic cancer (PerSeUS-GP-01)
Region
Japan

Condition
Condition Locally advanced pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of neoadjuvant chemoradiation therapy using S-1 for locally advanced pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1-year survival rate
Key secondary outcomes progression free survival, surgical resection rate, curative resection rate, effective rate and complication rate of the neoadjuvant chemoradiation therapy, 5-year survival rate

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 Maneuver
Interventions/Control_1 Surgical resection after chemoradiation therapy.
S-1 administration after the surgical resection.
Radiation therapy concurrently with S-1:
S-1; 80mg/m2/day (administration on the day of radiation therapy)
Radiation therapy; a total dose of 39.6Gy by 22 fractions.
Post operative chemotherapy with S-1:
S-1; 80mg/m2 administration for 14 days, followed by a resting period for 7 days.
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 Inclusion criteria :
1. Pancreatic cancer whose diagnosis was confirmed by pathological or imaging results.
2. Possibly resectable locally advanced pancreatic cancer,
fulfilled at least one of the following criteria on CT findings:
1) Retroperitoneal invasion (RP): Shaggy sign of peripancreatic tissue is presented.
2) Direct invasion to the portal system (PV): Tumor causes deformity of the PV, but contacts it less than 1/4 circle, or no deformity but contacts more than 1/4 circle.
3)Direct invasion to the arteries (A): Tumor causes no deformity, and contacts them less than 1/4 circle.

Not fulfilled any of the following criteria on CT findings:
4)Retroperitoneal invasion (RP): Tumor invades definitively to the inferior vena cava or aorta.
5)Direct invasion to the portal system (PV): Tumor causes severe stenosis or obstruction of the PV.
6)Invasion to the arteries (A): Tumor causes deformity or contacts them more than 1/4 circle.
3. presence of measurable lesions.
4. without prior history of the treatment such as surgical operation, radiotherapy, and chemotherapy for the lesion.
5. ECOG performance status : 0-1.
6. Normal oral intake.
7. Sufficient organ function:
Leukocytes: >= 3,500/mm2
Neutrophil: >= 2,000/mm2
Platelets: >= 100,000/mm2
Hemoglobin: >= 9g/dL
Serum total bilirubin: <= 2.0mg/dL (or 3.0mg/dL in cases after biliary drainage)
Serum transaminases: AST <= 100U/L (or 150U/L in cases after biliary drainage), ALT <= 100U/L (or 150U/L in cases after biliary drainage)
Serum creatinine: <= 1.2mg/dL
Creatinine clearance: >= 50ml/min (option)
8. Life expectancy of more than 3 months.
9. Written informed consent.
Key exclusion criteria 1. Lung fibrosis or interstitial pneumonia. (should be confirmed by chest radiograph or CT within 28 days before the entry)
2. Watery diarrhea or chronic diarrhea
3. Regular use of Fenitoin, Warfarin or Frucitocin.
4. Pleural effusion or ascites.
5. Active infection.
6. Other malignancies.
7. Active gastroduodenal ulcer.
8. Serious comorbid illness. (heart failure, renal failure, liver failure, intestinal paralysis, uncontrolled diabetes, etc)
9. Serious mental disorder.
10. Serious drug allergy.
11. During pregnancy or lactation.
12. Patients who were judged inappropriate for the entry to this study by the investigators.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisataka Moriwaki
Organization Gifu University
Division name Dept. of Gastroenterology
Zip code
Address 1-1 Yanagido, Gifu 501-1194, Japan
TEL 058-230-6308
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ichiro Yasuda
Organization Gifu University
Division name Dept. of Gastroenterology
Zip code
Address 1-1 Yanagido, Gifu 501-1194, Japan
TEL
Homepage URL
Email

Sponsor
Institute PerSeUS-GP
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Gifu Prefectural Medical Center
Gifu Municipal Hospital
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
2009 Year 08 Month 01 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
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2013 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 09 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002597

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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