UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040948 |
|---|---|
| Receipt number | R000046756 |
| Scientific Title | A prospective study of the efficacy and safety of preoperative chemotherapy with gemcitabine+nab-paclitaxel therapy for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image. |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2022/08/26 16:52:00 |
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Basic information
Public title
A prospective study of the efficacy and safety of preoperative chemotherapy with gemcitabine+nab-paclitaxel therapy for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image.
Acronym
A prospective study of the efficacy and safety of preoperative chemotherapy for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image.
Scientific Title
A prospective study of the efficacy and safety of preoperative chemotherapy with gemcitabine+nab-paclitaxel therapy for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image.
Scientific Title:Acronym
A prospective study of the efficacy and safety of preoperative chemotherapy for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image.
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of preoperative chemotherapy with gemcitabine+nab-paclitaxel for the survival period for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival after initiation of protocol treatment
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.In the case which the primary tumor is confirmed to be pancreatic cancer by histological diagnosis, cytological diagnosis, or image examination, the degree of progress diagnosis is performed by image examination, and it becomes resectable pancreatic body cancer according to NCCN guideline (Version 1.2020). Among the matching cases, resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image diagnosis.
2.Cases with measurable lesions
3.Initial treatment case
4.Cases with 0 or 1 Performance status (ECOG)
5.Cases with 20 years or older
6.Cases which the functions of major organs meet the following criteria (latest value within 14 days before registration)
White blood cell: <12,000/mm3
Neutrophil: >1,500/mm3
Hemoglobin value: >9.0g/dL
Platelet: >100,000 /mm3
Total bilirubin: less than 2.0 mg/dL (less than 3.0 mg/dl in jaundice cases)
Serum creatinine: <1.5 mg/dL
AST and ALT: 2.5 x below facility standard upper limit
7.Cases in which consent was obtained by the patient's signature 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
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 with uncontrolled diabetes
8. Cases with Uncontrolled congestive heart failure, angina, hypertension, arrhythmia
9. Cases with history of neurologically or psychologically significant disease
10. Cases with diarrhea
11. Pregnant women, lactating women, and women who may be pregnant (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 study drug
12. Other cases that the doctor has determined to be unsuitable for participation in this clinical trial
13. Cases which conforms to Borderline Resectable/Unresectable of NCCN guidelines (Version 1.2020) by MDCT diagnosis.
14. Patients with active hepatitis B
Target sample size
49
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kaiwai |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama city
TEL
0734410613
kawai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kitahata |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama city
TEL
0734410613
Homepage URL
yuji-kh@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university
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
Wakayama medical university
Address
2nd department of surgery
Tel
0734410613
yuji-kh@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 | 07 | Month | 01 | 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 | 06 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2020 | Year | 06 | Month | 29 | Day |
Last modified on
| 2022 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046756
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| Registered date | File name |
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