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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040948
Receipt No. 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 2020/06/30

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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 Hiroki
Middle name
Last name Yamaue
Organization Wakayama medical university
Division name 2nd department of surgery
Zip code 641-8510
Address 811-1 Kimiidera, Wakayama city
TEL 0734410613
Email yamaue-h@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
Email yuji-kh@wakayama-med.ac.jp

Sponsor
Institute Wakayama medical university
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 29 Day
Date of IRB
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
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046756

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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