UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomised Phase II trial investigating the duration of adjuvant therapy(6 versus 12 months) with S-1 for patients after resection of pancreatic cancer
Title of the study (Brief title)	Postoperative Adjuvant Chemotherapy S-1 : PACS-1
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 efficacy and safety of the duration of adjuvant therapy (6 versus 12 months) with S-1 for patients after resection of pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	2-year overall survival rate
Key secondary outcomes	DFS, OS, Dose Intensity, Complete rate of each treatment point (3 and 6, 9, 12 months), Safety

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	S-1 40 mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. This course is repeated until 6 months or to meet discontinuation criteria.
Interventions/Control_2	S-1 40 mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. To be repeated until 12 months or to meet discontinuation criteria.
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	1) Patients with written informed consent 2) Patients who are judged to be suitable for receiving this protocol therapy by the physician 3) Resected cases with histologically proven invasive ductal carcinoma of the pancreas 4) According to the UICC 7th classification; - Stage I or II, or III in whom celiac artery resection was performed - R0 or R1 - Cancer negative for washing cytology of the abdominal cavity 5) No distant metastasis nor malignant ascites 6) Adequate oral intakes 7) Aged 20 years and older 8) An Eastern Cooperative Oncology Group performance status of 0 or 1 9) No prior history of chemotherapy nor radiation therapy within three years 10) Within 10 weeks after operation 11) Sufficient organ function of bone marrow, liver, and kidney: 12) Patients with laboratory data within 14days before enrollment as follows; 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
Key exclusion criteria	1) Previously treated by chemotherapy for locally advanced pancreatic cancer 2) Prior history of S-1 therapy 3) History of serious drug hypersensitivity or a history of drug allergy 4) Patients with contraindication for the medication of S-1 5) Serious complications ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, intractable diabetes, intractable hypertension) 6) Recurrent disease before enrollment 7) Moderate or ascites or pleural effusion 8) Plumonary fibrosis or interstitial pneumonia diagnosed by chest X-ray. 9) Serious diarrhea 10) Myocardial infarction within six months 11) Active infection(fever up; over 38 degree) 12) Blood transfusion within 2 weeks before enrollment 13) Severe mental disorder 14) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free survival of 5 years or less). 15) Pregnant or lactating woman and man who hope for partner&#39;s pregnancy 16) Patients who need flucytosine, phenytoin or warfarin potassium. 17) Requiring continous steroid administration 18) Not appropriate for the study at the physician&#39;s assessment
Target sample size	170

Research contact person
Name of lead principal investigator	Yoshihiko MAEHARA
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL	092-642-5466
Email	abesato@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person	Norifumi HARIMOTO
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL	092-642-5466
Homepage URL
Email	abesato@surg2.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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)

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	九州大学病院（福岡県）、済生会福岡総合病院（福岡県）、九州中央病院（福岡県）、九州がんセンター（福岡県）、福岡市民病院（福岡県）、飯塚病院（福岡県）、大分赤十字病院（大分県）、大分県立病院（大分県）、別府医療センター（大分県）、熊本大学大学院生命科学研究部（熊本県）、済生会熊本病院（熊本県）、広島赤十字・原爆病院（広島県）、徳島大学大学院ヘルスバイオサイエンス研究部（徳島県）、松山赤十字病院（愛媛県）、東京慈恵会医科大学（東京都）、群馬大学大学院（群馬県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 12 Month 16 Day
Anticipated trial start date	2013 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 12 Month 20 Day
Last modified on	2017 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014772