UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)
Acronym	Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)
Scientific Title	Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)
Scientific Title:Acronym	Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)
Region	Japan

Condition
Condition	Patients with locally advanced pancreatic cancer (BR-A or UR-LA) scheduled for pancreatic resection
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of present study is to confirm the safety and efficacy of chemoradiotherapy using gemcitabine plus nab-paclitaxel (GEM+nab-PTX) as preoperative chemoradiotherapy for locally advanced pancreatic cancer after primary chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Phase I study: Incidence of dose-limiting toxicities (DLT) Phase II study: 2-year survival rate
Key secondary outcomes	Phase I study: Response rate Disease control rate Safety (incidence and severity of adverse events) Phase II study: Overall survival Progression-free survival Response rate Disease control rate Tumor marker decrease rate Surgical procedure Intraoperative blood loss Operation time Resection rate R0 resection rate Incidence of postoperative pancreatic fistula Postoperative hemorrhage Incidence of DGE Incidence of diarrhea Other postoperative complications Safety (incidence and severity of adverse events)

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	Preoperative chemoradiotherapy using gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer after primary chemotherapy. gemcitabine plus nab-paclitaxel therapy: gemcitabine plus nab-paclitaxel are administered intravenously on days 1 and 8 of a 21-day course. This is done for two courses. radiation: 1.8 Gy per day, 5 times a week, total of 28 fractionation (total dose 50.4 Gy/28 fr).
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Pancreatic cancer (invasive ductal carcinomas) diagnosed by imaging and pathological examination 2) No evidence of distant metastasis 3) Patients diagnosed with BR-A or UR-LA pancreatic cancer, who have received at least 3 courses of gemcitabine plus nab-paclitaxel as primary chemotherapy, whose efficacy is judged to be CR/PR/SD, and who are technically considered to be resectable and are planning to undergo surgery. 4) Age: between 20 and 80 years old 5) Performance status (ECOG): 0 or 1 6) Tumor is measurable on imaging CT 7) No history of chemotherapy, hormonal therapy, or molecular targeted therapy other than the above 8) No history of radiation therapy to the abdomen 9) Appropriate biliary drainage is performed in cases of obstructive jaundice. 10) No direct invasion of the gastrointestinal tract on imaging findings 11) No evidence of concurrent cancer of other organs 12) adequate major organ function (1) Leukocyte count: >=3500 /mm3, <12000 /mm3 (2) Neutrophil count: >=2000 /mm3 (3) Hemoglobin: >=9.0 g/dL (4) Platelet count: >=100000 /mm3 (5) Total bilirubin: <=2.0 mg/dL (<=3.0 mg/dL: patients undergoing drainage for obstructive jaundice) (6) AST: <=150 U/L, ALT: <=150 U/L (7) Creatinine: <=1.2 mg/dL (8) Creatinine clearance: >=50 mL/min 13) Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria	1) Active multiple cancers 2) Patients whose dose of GEM+nab-PTX in primary chemotherapy was reduced to less than 600 mg/m2 of GEM or less than 75 mg/m2 of nab-PTX 3) Patients who were refractory or intolerant to primary GEM+nab-PTX and were switched to other chemotherapy 4) Infection or inflammation that requires systemic treatment 5) Fever of 38.0 degrees Celsius higher at the time of registration 6) Allergy or contraindication to gemcitabine or paclitaxel 7) History of severe drug hypersensitivity or drug allergy 8) Allergy to contrast media 9) History of serious heart disease 10) History of serious underlying diseases (poorly controlled diabetes, renal failure, liver cirrhosis, etc.) 11) Poorly controlled ascites or pleural effusion 12) Active gastrointestinal bleeding requiring repeated blood transfusions. 13) Diarrhea (more than 4 times a day or watery stools) 14) Poorly controlled cancer pain 15) Pulmonary fibrosis or interstitial pneumonia with obvious or clinical findings on imaging 16) Lung field enters the radiation field 17) Pregnant or lactating women or those with the potential (intention) to become pregnant 18) Severe psychological or neurological disease 19) Unable to give consent to participate in this study
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Fujii Middle name Last name Tsutomu
Organization	Faculty of Medicine, Academic Assembly, University of Toyama
Division name	Department of Surgery and Science
Zip code	9300194
Address	2630, Sugitani, Toyama
TEL	076-434-7331
Email	fjt@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Kazuto Middle name Last name Shibuya
Organization	Faculty of Medicine, Academic Assembly, University of Toyama
Division name	Department of Surgery and Science
Zip code	9300194
Address	2630, Sugitani, Toyama
TEL	076-434-7331
Homepage URL
Email	shibuyak@med.u-toyama.ac.jp

Sponsor
Institute	Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
Institute
Department

Funding Source
Organization	Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for Clinical Research, Toyama University Hospital
Address	2630, Sugitani, Toyama
Tel	076-434-7331
Email	rinri@adm.u-toyama.ac.jp

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	2022 Year 02 Month 10 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	Open public recruiting
Date of protocol fixation	2021 Year 12 Month 20 Day
Date of IRB	2022 Year 02 Month 18 Day
Anticipated trial start date	2022 Year 02 Month 28 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 13 Day
Last modified on	2022 Year 05 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053085