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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026858
Receipt No. R000030821
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
Date of disclosure of the study information 2017/04/06
Last modified on 2019/04/23

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000030821

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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