UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study on preoperative algorithm treatment for Borderline Resectable Pancreatic Cancer with positive radiological arterial invasion
Acronym	Prospective study on preoperative algorithm treatment for BRPC-A
Scientific Title	Prospective observational study on preoperative algorithm treatment for Borderline Resectable Pancreatic Cancer with positive radiological arterial invasion
Scientific Title:Acronym	Prospective study on preoperative algorithm treatment for BRPC-A
Region	Japan

Condition
Condition	Borderline Resectable Pancreatic Cancer with positive radiological arterial invasion
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Establishing an algorithmic treatment based on the evaluation of the therapeutic effect of induction chemotherapy for resectable borderline pancreatic cancer with positive arterial invasion, which has extremely poor outcome even after preoperative treatment, truly benefits surgical treatment. By clarifying the group of patients who receive it, and continuing non-surgical treatment otherwise, we demonstrate improvement in overall survival of borderline resectable pancreatic cancer with positive arterial invasion. The treatment results (total survival time, recurrence-free survival time, 1-year recurrence rate) of resectable borderline pancreatic cancer with positive arterial invasion according to the conventional treatment policy reported by our department to the treatment results of algorithm treatment (protocol completion) rate, overall survival, recurrence-free survival, 1-year recurrence rate).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total algorithm treatment compliance rate
Key secondary outcomes	1. Total number of registered cases and overall survival of each treatment group 2. Total number of registered cases and recurrence-free survival time for each treatment group 3.1 year recurrence rate

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. In the case where the primary lesion is confirmed to be pancreatic cancer by histology, cytology, or imaging examination, MDCT is used to diagnose the degree of progression, and NCCN guidelines (Version 1.2020) are applied to Borderline Resectable Pancreatic Carcinoma-Arterial (BRPC-A) 2. Initial treatment case 3. Performance status (ECOG) is 0 or 1 4. Cases where the age at the time of obtaining consent is 20 years or older and less than 80 years old 5. Cases where the functions of major organs meet the following criteria (latest value within 14 days before registration) White blood cells <=12,000/mm3 Neutrophil >=1,500/mm3 Hemoglobin value >=9.0g/dL Platelet >=100,000/mm3 Total bilirubin less than 2.0 mg/dL(3.0 mg/dL or less in obstructive jaundice cases) Serum creatinine<=1.5 mg/dL AST and ALT 2.5xbelow the facility upper limit 6. Cases in which consent for the participation in this study was obtained by the signature of the person before registration
Key exclusion criteria	1. Cases with a history of severe drug hypersensitivity or drug allergy 2. Cases with a history of malignant tumor (* If there is a recurrence-free period of 5 years or more, and endoscopically curatively resected intramucosal cancer, curatively resected cervical cancer, and basal cell carcinoma of the skin Or squamous cell carcinoma can be registered) 3. Cases with active infection 4. Patients with peripheral sensory neuropathy (Grade 2 or higher) 5. Cases with a history of interstitial pneumonia or pulmonary fibrosis 6. Patients with uncontrolled ascites or pleural effusion 7. Cases receiving atazanavir sulfate 8. Cases with uncontrolled diabetes 9. Uncontrollable congestive heart failure, angina, hypertension, arrhythmia 10. History of neurologically or psychologically significant disease, and cases with complications 11. Cases with diarrhea (including increased number of stools and watery stools) 12. Pregnant women, lactating women, and cases of possible pregnancy (will), or women and men who are not willing to contracept during the study period and for a certain period (180 days) after the last administration of the study drug 13. Patients with active hepatitis B 14. Regarding UGT1A1*6 and *28 gene polymorphisms, have either of them as homozygotes (UGT1A1*6/*6, UGT1A1*28/*28) or both as heterozygotes (UGT1A1*6/*28) Case
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Ken-ichi Middle name Last name Okada
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama
TEL	0734410613
Email	okada@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Ken-ichi Middle name Last name Okada
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama
TEL	0734410613
Homepage URL
Email	okada@wakayama-med.ac.jp

Sponsor
Institute	Second Department of Surgery, Wakayama Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama
Tel	0734472300
Email	warinri@wakayama-med.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	2020 Year 06 Month 16 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	2020 Year 05 Month 20 Day
Date of IRB	2020 Year 06 Month 03 Day
Anticipated trial start date	2020 Year 06 Month 16 Day
Last follow-up date	2025 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 06 Month 16 Day
Last modified on	2020 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046581