UMIN-CTR Clinical Trial

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
Email	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
Email	dyamada@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Clinical study group of Osaka university, Hepato-Biliary- Pancreatic group
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024781