UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neoadjuvant radiation therapy concurrent with S-1 followed by systemic Gemcitabine therapy for Borderline resectable pancreatic cancer patients; A phase2 study
Title of the study (Brief title)	A phase2 study of neoadjuvant S1+RT followed by systemic Gem therapy for Borderline resectable pancreatic cancer patients
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery Radiology Operative medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the safety, the efficacy and the feasibility of neoadjuvant radiation concurrent with S-1 followed by systemic Gemcitabine therapy for borderline resectable pancreatic cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	R0 resection rate
Key secondary outcomes	completion rate, pathological effect , Response rate, CA19-9 response rate, progression free survival, distant metastasis free survival, overall survival, adverse effect, surgical complication

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
Interventions/Control_1	Concurrent radiotherapy with S-1: S-1 (80mg/m2) on the irradiated day, Radiotherapy; a total dose of 50.4 Gy in 28 fractions. Systemic Gemcitabine therapy: Gemcitabine (1000mg/m2) is given by intravenous infusion over 30 min on days 1, 8, 15 every 4 week. This cycle was repeated 3 cycles.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Pathologically or cytologically proven diagnosis of pancreas cancer. 2) Definition of a Borderline resectable pancreatic cancer is filled in NCCN guidelines 2012 pancreatic adenocarcinoma 3) No hepatic metastasis by EOB-MR 4) Patients of age =>20 and 75> 5) Performance Status:0-1 (ECOG) 6) Adequate oral intake 7) Good main organ function 8) Written informed consent
Key exclusion criteria	1) treatment history of a pancreatic cancer (chemotherapy, radiotherapy, surgical) 2) treatment history of other malignant tumors (chemotherapy, radiotherapy) 3) Patients who can' t receive neither iodic drug because of drug allergy 4) Including in an exposure field is impossible with contrast enhanced CT 5) Massive pleural or abdominal effusion 6) Pleural membranes and peritoneum sowing are proved by cytological diagnosis 7) Existence of tumor exposure with CT or Endoscope 8) Hemorrhagic peptic ulcer 9) Watery diarrhea 10) Regular use of frucitocin, fenitoin or warfarin 11) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings 12) Severe infection 13) Serious complications (e.g. heart failure, hepatic failure, intestinal paralysis, intestinal obstruction) 14) Uncontrolled diabetes 15) Simultaneous or metachronous (within 3 years) double cancers 16) Patients requiring systemic steroids medication 17) Severe mental illness 18) Severe drug hypersensitivity 19) Males that are currently attempting to produce a pregnancy 20) Pregnant females, possibly pregnant females, females wishing to become pregnant 21) Patients seems inadequate for this study by investigators
Target sample size	45

Research contact person
Name of lead principal investigator	Tsuyoshi Hayashi
Organization	Sapporo Medical University
Division name	Department of Medical Oncology and Hematology
Address	S1, W16, Chuoku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Email	thayashi69@sapmed.ac.jp

Public contact
Name of contact person	Tsuyoshi Hayashi
Organization	Sapporo Medical University
Division name	Department of Medical Oncology and Hematology
Address	S1, W16, Chuoku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Homepage URL
Email	thayashi69@sapmed.ac.jp

Sponsor
Institute	Hokkaido Pancreatic Cancer Study Group (HOPS)
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

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 01 Day
Anticipated trial start date	2013 Year 11 Month 15 Day
Last follow-up date	2017 Year 04 Month 28 Day
Date of closure to data entry	2017 Year 08 Month 31 Day
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 11 Month 14 Day
Last modified on	2017 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014362