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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024154
Receipt No. R000027812
Scientific Title Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with borderline resectable pancreatic cancer.
Date of disclosure of the study information 2016/10/01
Last modified on 2019/09/28

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Basic information
Public title Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with borderline resectable pancreatic cancer.
Acronym Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with BRPC.
Scientific Title Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with borderline resectable pancreatic cancer.
Scientific Title:Acronym Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with BRPC.
Region
Japan

Condition
Condition Invasive ductal adenocarcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy on survival time of NAC-GA therapy as neoadjuvant chemotharpy for borderline resectable pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival time from the first day of protocol therapy
Key secondary outcomes 1.Recurrence free survival from the first day of protocol therapy
2.Safety of the protocol therapy(Adverse effect)
3.Morbidity based on Clavien Dindo classification of more than Grade3
4.Response rate, preoperative/postoperative tumor marker (CA19-9, CEA), rate of mornalization, reduction rate of SUVmax value on PET-CT(limited only for PET-CT available institutions)
5.Chemotherapeutic effect grade based on Evans classification.
6.Resection rate
7.R0 resection rate
8.Surgical data(operative time, blood loss,transfusion, postoperative hospital day)
9.The overall morbidity rates(Reoperation, rate of re-admission, mortality)
10.Number of patient rate in postoperative adjuvant therapy(entry rate, completion rate)
11.Dose intensity

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 neoadjuvant chemotherapy 2 courses of NAC-GA
1.nab-paclitaxel (Day1,8,15) 125mg/m2 30 min div administration
2.Gemcitabine (Day1,8,15) 1,000mg/m2 30 min div administration
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. Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline resectable-venous
2.case with measurable lesion
3.First line treatment
4.PS(ECOG)0-1
5.>=20 years old and <80 years old
6.The following criteria must be satisfied in laboratory tests within 14 days of registration
WBC count<=12,000/mm3
Neutrophil count>=1,500/mm3
Hb>=9.0g/dl
Plt >=100,000/mm3
T.Bil <2.0mg/dl (<3=.0mg/dl in biliary drainage case)
Serum Cr<=upper limits of normal (ULN)
AST, ALT<=2.5xULN
7. Written informed consent to participate in this study
Key exclusion criteria 1.Severe drug hypersensitivity
2.Multiple primary cancers within 5 years
3.Severe infection
4.With grade2 or more severe peripheral neuropathy
5.Interstitial pneumonia or pulmonary fibrosis
6.With uncontrollable pleural effusion or ascites
7.With uncontrollable diabetes mellitus
8.With uncontrollable heart failure, angina, hypertension, arrhythmia
9.With severe neurological/psychological symptoms
10.With watery diarrhea
11.Pregnant or lactating women or women with unknown or suspected pregnancy
12.Inappropriate patients for entry on this study in the judgement of the investigator
13.Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Yamaue
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address Kimiidera 811-1, Wakayama City
TEL 073-441-0613
Email yamaue-h@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 Kimiidera 811-1, Wakayama City
TEL 073-441-0613
Homepage URL
Email okada@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

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

IRB Contact (For public release)
Organization IRB of Wakayama Medical University
Address Kimiidera 811-1, Wakayama City
Tel 073-447-2300
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 和歌山県立医科大学附属病院(和歌山県)、京都府立医科大学附属病院(京都府)、関西医科大学附属病院(大阪府)、大阪医科大学附属病院(大阪府)、神戸大学附属病院(兵庫県)、大阪大学附属病院(大阪府)、大阪市立大学附属病院(大阪府)、奈良県立医科大学附属病院(奈良県)、近畿大学附属病院(大阪府)、名古屋大学附属病院(愛知県)、広島大学附属病院(広島県)、熊本大学附属病院(熊本県)、弘前大学附属病院(青森県)、京都大学附属病院(京都府)、千葉大学附属病院(千葉県)、滋賀医科大学附属病院(滋賀県)、兵庫医科大学附属病院(兵庫県)、岐阜大学附属病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 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
2016 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 25 Day
Last modified on
2019 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027812

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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