UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial of gemcitabine hydrochloride plus S-1 combination (GS) therapy and gemcitabine hydrochloride (Gem) therapy alone for patients with pancreatic cancer who are 75 years or older.
Title of the study (Brief title)	Gemcitabine and TS-1 Trial-2
Region	Japan

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

Objectives
Narrative objectives1	To compare the efficacy and safety of gemcitabine hydrochloride (Gem) plus S-1 combination therapy (GS therapy) with standard Gem therapy alone in patients with pancreatic cancer who are 75 years old or older in good performance status in a randomized controlled trial.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Incidence rate of adverse event, incidence rate of serious adverse event, progression-free survival, response rate

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A (a group for Gem therapy alone): Gem is intravenously administered at a dose of 1,000 mg/m^2/day in 30 minutes on day 1, day 8 and day 15 as 4 weeks (28 days) for 1 course, until it satisfies any of the discontinuation criteria. The observation period is the period from the start of treatment to the completion of the later of 6 courses and 24 weeks.
Interventions/Control_2	Group B (a group for GS therapy): Gem is intravenously administered at a dose of 1,000 mg/m^2/day in 30 minutes on day 1 and day 8. S-1 is orally administered at a dose according to body surface (60 mg, 80 mg or 100 mg/day) in 2 divided doses after breakfast and after supper for 14 days continuously, followed by the rest period of 7 days. Treatment is continued as 2 weeks (14 days) for 1 course until it satisfies any of the discontinuation criteria. The observation period is the period from the start of treatment to the completion of the later of 8 courses and 24 weeks.
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who are diagnosed with adenocarcinoma in tissue biopsy or cytology and whose image diagnosis do not contradict any of papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma or adenous squamous cell carcinoma. 2. Patients who are diagnosed with either locally advanced (UICC T4N0-1 M0: stage III), distant metastasis (UICC M1: stage IV) or recurrent (after resection) pancreatic cancer in clinical and image diagnoses. 3. Patients without retention of body cavity fluid (pleural effusion, ascites) which requires puncture drainage on chest x-rays and abdominal CT. 4. Patients who are 75 years old or older at the time of registration. 5. Patients with performance status (ECOG) of grade 0 or 1. 6. Patients without a history of chemotherapy for pancreatic cancer. 7. Patients who have had rest period of a half year or more since the end of prior treatment of either chemotherapy or radiotherapy for other cancer types. 8. Patients who satisfies all of the following conditions. 1).White blood cell count => 3,000 /mm^3 and <= 12,000 /mm^3 2).Hemoglobin => 9.0 g/dL (without transfusion within 14 days until the time of registration) 3).Number of platelets => 10*10^4 /mm^3 4).Albumin => 3.0g/dL 5).Total bilirubin without preoperative biliary drainage: <= 2.0 mg/dL, with preoperative biliary drainage: <= 3.0 mg/dL 6).AST without preoperative biliary drainage: <= 100 IU/L, with preoperative biliary drainage <= 150 IU/L 7).ALT without preoperative biliary drainage: <= 100 IU/L, with preoperative biliary drainage: <= 150 IU/L 8).Creatinine clearance => 50 mL/min/body 9).CRP <= 2.0 mg/dL 9. Patients who provided written consents for this study by themselves.
Key exclusion criteria	1. Patients to whom gemcitabine hydrochloride plus nab-paclitaxel (brand name: Abraxane) can be introduced at the discretion of the attending doctor under consent of the patient. 2. Patients with active advanced multiple primary cancers with life expectancy within a half year. 3. Patients with a bacterial infection which requires systemic treatment by intravenous administration of antibiotic. 4. Patients with a complication of psychosis or psychiatric symptoms (including dementia) who are decided not suitable for participation in this study. 5. Patients who have undergone continuous systemic administration of steroids. 6. Patients with pulmonary fibrosis or interstitial pneumonia. 7. Patients with serious complications. 8. Patients with a complication of unstable angina or a history of myocardial infarction within 6 months. 9. Patients who require continuous administration of flucytosine, phenytoin and warfarin potassium. 10. Patients to whom neither iodine drug nor gadolinium can be used for drug allergy. 11. Patients for whom the principal investigator or other investigators decided not suitable for participation in this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroshi Ishii
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Clinical Research Center
Address	160 Kou, Minamiumemoto-machi, Matsuyama, Ehime, 791-0280, JAPAN
TEL	089-999-1111
Email	hirishii@gmail.com

Public contact
Name of contact person	Hiroshi Ishii
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Clinical Research Center
Address	160 Kou, Minamiumemoto-machi, Matsuyama, Ehime, 791-0280, JAPAN
TEL	089-999-1111
Homepage URL
Email	hirishii@gmail.com

Sponsor
Institute	National Hospital Organization Shikoku Cancer Center
Institute
Department

Funding Source
Organization	National Hospital Organization
Organization
Division
Category of Funding Organization	Other
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	北海道がんセンター(北海道)、水戸医療センター(茨城県)、高崎総合医療センター(群馬県)、渋川医療センター(群馬県)、まつもと医療センター(長野県)、敦賀医療センター(福井県)、京都医療センター(京都府)、大阪医療センター(大阪府)、神戸医療センター(兵庫県)、米子医療センター(鳥取県)、岡山医療センター(岡山県)、福山医療センター(広島県)、関門医療センター(山口県)、岩国医療センター(山口県)、四国がんセンター(愛媛県)、小倉医療センター(福岡県)、九州がんセンター(福岡県)、九州医療センター(福岡県)、熊本南病院(熊本県)、別府医療センター(大分県)、南九州病院(鹿児島県)、がん研究会有明病院(東京都)、神奈川県立がんセンター(神奈川県)、大阪府立成人病センター(大阪府)、横浜医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 12 Month 20 Day
Anticipated trial start date	2017 Year 02 Month 18 Day
Last follow-up date	2018 Year 02 Month 16 Day
Date of closure to data entry	2018 Year 02 Month 16 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	https://bmjopengastro.bmj.com/content/5/1/e000187.citation-tools
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 19 Day
Last modified on	2019 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029624