UMIN-CTR Clinical Trial

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
Last 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
1st 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