UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomiszd phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 in patients with resected pancreatic cancer
Title of the study (Brief title)	Randomized phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 for pancreatic cancer (JASPAC 01)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate non-inferiority in survival following adjuvant chemoterpy with S-1 against gemcitabine in patients with resected pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Incidence of adverse events Relapse-free survival Health-related quality of life

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Gemcitabine 1000 mg/m2 is given by intravenous infusion over 30 minutes on days 1, 8, and 15, followed by a 1-week pause. This cycle is repeated for six months or until recurrent disease is confirmed.
Interventions/Control_2	S-1 40mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. This course is repeated four times or until recurrent disease is confirmed.
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	Eligible criteria are as follows: 1) Resected cases with histologically proven invasive ductal carcinoma of the pancreas 2) According to the UICC classification, a) Stage I or II, or III in whom celiac artery resection was performed b) R0 or R1 c) Cancer negative for washing cytology of the abdominal cavity 3) No distant metastasis nor malignant ascites 4) Adequate oral intakes 5) Aged 20 years or older 6) An Eastern Cooperative Oncology Group performance status of 0 or 1 7) No prior history of chemotherapy nor radiation therapy within three years 8) Within 10 weeks after operation 9) Sufficient organ function: leukocytes >= 3,000 /mm3 and <= 12,000 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 8.0 g/dL, serum total bilirubin <= 2.0 mg/dL, serum aspartate aminotransferase (AST) <= 100 IU/L, serum alanine aminotransferase (ALT) <= 100 IU/L, and serum creatinine <= 1.2 mg/dL 10) Written informed consent
Key exclusion criteria	Exclusion criteria are as folllows: 1) Prior history of gemcitabine therapy or S-1 therapy 2) Recurrent disease on enrollment 3) Massive ascites or pleural effusion 4) Plumonary fibrosis or interstitial pneumonia 5) Severe diarrhea 6) NYHA III or IV cardiac function 7) Myocardial infarction within six months 8) Severe infection 9) Severe diabetes 10) Blood transfusion within two weeks 11) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc 12) Severe mental disorder 13) Severe drug allergy 14) Other active malignancy 15) Pregnancy, breast feeding, or women who desire to preserve fecundity 16) Men who desire to have children 17) Regular use of frucitocin, fenitoin or warfarin 18) Inadequate physical condition, as diagnosed by primary physician
Target sample size	360

Research contact person
Name of lead principal investigator	Katsuhiko Uesaka
Organization	Shizuoka Cancer Center Hospital
Division name	Division of Hepato-Biliary-Pancreatic Surgery
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
TEL	055-989-5222
Email	k.uesaka@scchr.jp

Public contact
Name of contact person	Katsuhiko Uesaka
Organization	Shizuoka Cancer Center Hospital
Division name	Division of Hepato-Biliary-Pancreatic Surgery
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
TEL	055-989-5222
Homepage URL
Email	k.uesaka@scchr.jp

Sponsor
Institute	Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Institute
Department

Funding Source
Organization	Pharma Valley Center, Shizuoka Organization for Creation Industries
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	2007 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 02 Month 16 Day
Anticipated trial start date	2007 Year 04 Month 01 Day
Last follow-up date	2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2007 Year 03 Month 27 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000791