UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040792 |
|---|---|
| Receipt number | R000046581 |
| Scientific Title | Prospective observational study on preoperative algorithm treatment for Borderline Resectable Pancreatic Cancer with positive radiological arterial invasion |
| Date of disclosure of the study information | 2020/06/16 |
| Last modified on | 2020/06/16 21:27:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
okada@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046581
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
