UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033901 |
|---|---|
| Receipt number | 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 13:48:41 |
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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
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
k-ishido@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038663
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