UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021484 |
|---|---|
| Receipt number | R000024781 |
| Scientific Title | Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2022/09/19 12:06:36 |
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Basic information
Public title
Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma
Acronym
PDAC-GS/GA-rP2, CSGO-HBP-015
Scientific Title
Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma
Scientific Title:Acronym
PDAC-GS/GA-rP2, CSGO-HBP-015
Region
| Japan |
Condition
Condition
Pancreatic ductal adenocarcinoma
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness and safety of the GEM /S-1 and the GEM/nab-PTX combination therapy in a randomization second aspect examination as preoperative therapy promising clinical benefit
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival time
Key secondary outcomes
Rate of curative resection, dose intensity, radiological/histological responses, recurrence type (if develop), overall survival and adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm 1:Gem+S-1 q3wx2times
Patients receive S-1(80mg/m2/day,day1-14) plus Gemcitabine(1000mg/m2,day1,15) every 3 weeks,2 times.
Interventions/Control_2
Arm 2:Gem+nab-PTX q4wx2times
Patients receive nab-PTX(125mg/m2, day1,15,22) plus Gemcitabine(1000mg/m2, day1,15,22) every 4 weeks, 2 times.
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. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
2. Patients of age =>20
3. Performance Status:0-1(ECOG)
4. Resectable pancreatic cancer
5. Life expectancy more than 6 months.
6. Sufficient organ functions.
(1) neutrophils >=1,500/mm3
(2) platelets >=100,000/mm3
(3) hemoglobin >=9.0g/dl
(4) AST(GOT)/ALT(GPT) <=150IU
(5) total bilirubin <=2.0mg/dl
(or <=3.0mg/dl if biliary drainage were present)
(6) serum creatinine <=1.2mg/dl
(7) creatinine clearance>=60ml/min
7. No treatment before application for this tumor
8. Written informed consent.
Key exclusion criteria
1) Unresectable pancreatic cancer
2) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
3) Watery diarrhea
4) Severe infection
5) Severe complication
(heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
6) Massive pleural or abdominal effusion.
7) Metastasis to central nervous system.
8) Active synchronous or metachronous malignancy other than carcinoma in situ.
9) Regular use of frucitocin, fenitoin or warfarin
10) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
11) Severe mental illness
12) Severe allergy for drugs
13) Patients who are judged inappropriate for the entry into the study by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Eguchi |
Organization
Graduate school of medicine, Osaka university
Division name
Department of Gastroenterological surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisaku |
| Middle name | |
| Last name | Yamada |
Organization
Graduate school of medicine, Osaka university
Division name
Department of Gastroenterological surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
Homepage URL
dyamada@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Clinical study group of Osaka university, Hepato-Biliary- Pancreatic group
Institute
Department
Personal name
Funding Source
Organization
Clinical study group of Osaka university, Hepato-Biliary- Pancreatic group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
Yamadaoka 2-2-Inovation center 4F, Suita
Tel
0662108296
handai-nintei@hp-crc.med.osaka-u.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
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05541-w
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 15 | Day |
Last modified on
| 2022 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024781
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| Registered date | File name |
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