UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002176 |
|---|---|
| Receipt number | 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 10:56:36 |
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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
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
Sponsor or person
Institute
PerSeUS-GP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002597
