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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033901
Receipt No. R000038663
Scientific Title Feasibility and potential benefits of preoperative chemotherapy with Gemcitabine+nab/Paclitaxel in patients with resectable pancreatic cancer: a multicenter phase I/II trial (APCS-01 study).
Date of disclosure of the study information 2018/09/15
Last modified on 2018/08/26

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Basic information
Public title Feasibility and potential benefits of preoperative chemotherapy with Gemcitabine+nab/Paclitaxel in patients with resectable pancreatic cancer: a multicenter phase I/II trial (APCS-01 study).
Acronym Multicenter phase I/II study of preoperative chemotherapy with Gemcitabine and nab/Paclitaxel for resectable pancreatic cancer (APCS-01).
Scientific Title Feasibility and potential benefits of preoperative chemotherapy with Gemcitabine+nab/Paclitaxel in patients with resectable pancreatic cancer: a multicenter phase I/II trial (APCS-01 study).
Scientific Title:Acronym Multicenter phase I/II study of preoperative chemotherapy with Gemcitabine and nab/Paclitaxel for resectable pancreatic cancer (APCS-01).
Region
Japan

Condition
Condition resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the safety and efficacy of preoperative chemotherapy with Gemcitabine and nab-Paclitaxel for resectable pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes relapse-free survival time
Key secondary outcomes completion rate of preoperative chemotherapy, over-all survival time, down-staging rate, R0 resection rate, adverse event rate, anti-tumor efficacy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Regimen of the chemotherapy: 1000mg/2 of Gemcitabine and 125mg/m2 of nab-Paclitaxel are administered.
Schedule: Gemcitabine and nab-Paclitaxel are administered once a week concurrently. A cycle is consisted of three weeks administration and a rest week.
Number of chemotherapy cycles is four, and the treatment period is four months.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Adenocarcinoma and adenosquamous carcinoma is confirmed pathologically.
2. No distant metastases are pointed out.
3. Resectability is diagnosed as "Resectable" according to General Rules for the Study of Pancreatic Cancer, 7th edition.
4. Radical surgery is tolerable.
5. No treatment history of pancreatic cancer.
6. Patient over 20 years old.
7. Good performance status (ECOG PS 0-1).
8. Appropriate biliary drainage has been performed when the patient had obstructive jaundice.
9. Main organ's functions are maintained.
10. Informed consent has been obtained in writing by the patient about the trial participation.
Key exclusion criteria 1. Patient with the treatment history of gemcitabine or nab/paclitaxel.
2. R0 resection is judged to be impossible.
3. Patient with sever diarrhea.
4. Patient with sever ascites and pleural effusion.
5. Patient with active other cancer.
6. Patient with sever coexisting disease.
7. Patients with active infectious disease.
8. Patient with remarkable abnormal electrocardiogram or sever cardiac disorder.
9. Patient with severe psychiatric disorder.
10. Pregnant female, lactating female, female who might be pregnant, female who hopes to be pregnant, and male who hopes the partner's pregnancy.
11. Patient with the history of sever medication allergy.
12. Patient with continuous systemic administration of the steroid.
13. Patient with contraindication of gemcitabine and nab-paclitaxel.
14. Patient where the attending doctor judged unsuitable for safely carrying out.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keinosuke Ishido
Organization Hirosaki University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 5 Zaifu-cho, Hriosaki, Aomori, Japan 036-8562
TEL 0172-39-5079
Email k-ishido@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keinosuke Ishido
Organization Hirosaki University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 5 Zaifu-cho, Hriosaki, Aomori, Japan 036-8562
TEL 0172-39-5079
Homepage URL
Email k-ishido@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization nothing
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
Address
Tel
Email

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
2018 Year 09 Month 15 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
2018 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 15 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
2018 Year 08 Month 26 Day
Last modified on
2018 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038663

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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