UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027758 |
|---|---|
| Receipt number | R000031808 |
| Scientific Title | Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for resectable and borderline resectable pancreatic cancer: Phase II study |
| Date of disclosure of the study information | 2017/06/14 |
| Last modified on | 2019/12/16 18:46:36 |
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Basic information
Public title
Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for resectable and borderline resectable pancreatic cancer: Phase II study
Acronym
GEM/nabPTX CRT for advanced pancreatic cancer
Scientific Title
Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for resectable and borderline resectable pancreatic cancer: Phase II study
Scientific Title:Acronym
GEM/nabPTX CRT for advanced pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Vascular surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this trial is to evaluate the treatment efficacy and safety of gemcitabine plus nab-paclitaxel and concurrent radiation therapy for resectable and borderline resectable pancreatic cancer as a preoperative treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Disease free survival, Response (either radiological or pathological), R0 resection rate, safety, pattern of recurrence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Induction chemotherapy with GEM/nPTX followed by GEM/nPTX CRT as a preoperative treatment for 3 months.
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients with resectable and borderline resecable pancreatic cancer (JPS-T3/4)
(2) PS(ECOG):0 or 1
(3) Adequate bone marrow reserves, liver/renal function:
WBC:>=3,500/mm3, <=12,000/mm3
Neutrophil: >=1,500/mm3
platelet: >=100,000/mm3
Hb: >=9.5g/dL
GOT,GPT,ALP: less than 2.5-fold of the upper limit of normal range
TBil: <=1.5mg/dL
Cr: <=1.2ng/dL
Ccr: >=50ml/min
(4) Life expectancy more than 6 months.
(5) Written informed consent.
Key exclusion criteria
(1)evident infection
(2)Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
(3)Severe complication(liver cirrhosis, uncontrolled diabetes etc)
(4)the onset of myocardial infarction within 3 months
(5)active synchronous malignancy
(6) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
(7)history of severe drug allergy
(8)neuropathy
(9)patients who are judged inappropriate for the entry of the trial by the investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Osaka International Cancer Institute
Division name
Gastroenterological Surgery
Zip code
541-8567
Address
3-1-69, Ohtemae, Chuo-ku, Osaka City, Japan
TEL
0669451181
takahasi-hi@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Dept. Surgery, Osaka International Cancer Institute
Division name
Gastroenterological Surgery
Zip code
541-8567
Address
3-1-69, Ohtemae, Chuo-ku, Osaka City, Japan
TEL
0669451181
Homepage URL
takahasi-hi@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Institute
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka City
Tel
06-6945-1181
rinri01@opho.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
大阪国際がんセンター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 14 | 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 | 31 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | 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 | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031808
