UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II/III study of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer
Acronym	GABARNANCE Trial
Scientific Title	Randomized phase II/III study of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer
Scientific Title:Acronym	GABARNANCE Trial
Region	Japan

Condition
Condition	Borderline Resectable Pancreatic Cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Objective of the study is to evaluate safety and efficacy of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	PhaseII part: R0 resection rate PhaseIII part: Overall survival
Key secondary outcomes	PhaseII part: Incidence of adverse events PhaseIII part: Progression free survival, R0 resection rate, 2 year survival rate, Radiological response rate, Histological response rate, Incidence of adverse events, Protocol compliance (completion rate of neoadjuvant therapy and overall therapy)

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 Maneuver
Interventions/Control_1	gemcitabine and nab-paclitaxel therapy as neoadjuvant therapy
Interventions/Control_2	S-1 and concurrent radiotherapy as neoadjuvant therapy
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Borderline resectable pancreatic cancer 2. Adenocarcinoma or adenosquamous carcinoma 3. No distant metastasis 4. Age 20-79 5. ECOG PS 0-1 6. No prior abdominal radiation therapy 7. No history of chemotherapy within last 3 years 8. No prior therapy for pancreatic cancer 9. Included in the irradiation field of 10cm x10cm 10. Able to eat orally 11. No sensory or motor neuropathy 12. Appropriate biliary drainage if bile duct obstructed 13. No radiological evidence of apparent intestinal cancer invasion and history of gastrointestinal bleeding 14. Meet all the criteria of laboratory examination 15. Informed consent by patient
Key exclusion criteria	1. History of gemcitabine, nab-paclitaxel and fluorouracil 2. poor control of diarrhea 3. Use of Coumadin, Phenytoin and Flucytosine 4. Allergic to gemcitabine and nab-paclitaxel 5. Computed tomography contrast media allergy 6. Intestinal pneumonia 7. Moderate amount of ascites or pleural effusion 8. Active infection 9. Poor control of diabetes mellitus 10. Ongoing active other malignancy 11. Active peptic ulcer 12. Serious comorbid conditions 13. Myocardial infarction within last 6 months 14. Systemic steroid therapy 15. Serious psychiatric diseases 16. Planning a baby or pregnancy 17. Planning a baby 18. Judged unable to guarantee safety
Target sample size	110

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shinichiro Takahashi
Organization	National Cancer Center Hospital East
Division name	Division of Hepatobiliary and Pancreatic Surgery
Zip code
Address	6-5-1 Kashiwanoha, Kashiwa city, Chiba 277-8577, JAPAN
TEL	+81-471-33-1111
Email	shtakaha@east.ncc.go.jp

Public contact
1st name of contact person	1st name Middle name Last name Yusuke Hashimoto
Organization	National Cancer Center Hospital East
Division name	Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address	6-5-1 Kashiwanoha, Kashiwa city, Chiba 277-8577, JAPAN
TEL	+81-471-33-1111
Homepage URL
Email	yushashi@east.ncc.go.jp

Sponsor
Institute	EPOC A1601/JASPAC07
Institute
Department

Funding Source
Organization	Japan agency of Medical Research and development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	国立がん研究センター東病院

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 06 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	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 09 Day
Date of IRB	2017 Year 03 Month 09 Day
Anticipated trial start date	2017 Year 04 Month 15 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 04 Month 04 Day
Last modified on	2019 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030821