UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026858 |
|---|---|
| Receipt number | 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 09:27:59 |
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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
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
yushashi@east.ncc.go.jp
Sponsor or person
Institute
EPOC A1601/JASPAC07
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030821
