UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012456 |
|---|---|
| Receipt number | R000014580 |
| Scientific Title | Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for borderline resectable pancreatic cancer: Phase I study |
| Date of disclosure of the study information | 2013/12/03 |
| Last modified on | 2017/06/14 17:57:27 |
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Basic information
Public title
Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for borderline resectable pancreatic cancer: Phase I study
Acronym
GEM/nabPTX CRT for BR pancreatic cancer
Scientific Title
Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for borderline resectable pancreatic cancer: Phase I study
Scientific Title:Acronym
GEM/nabPTX CRT for BR pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The trial objectives is to identify the maximum-tolerated dose (MTD) of gemcitabine plus nab-paclitaxel and concurrent radiation therapy for borderline resectable pancreatic cancer in the setting of preoperative treatment sequence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
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/n-P followed by GEM/n-P CRT.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients with BR pancreatic cancer involving 180 degree of less of the circumference of the SMA, CA, or CHA.
(2)Performance Status (ECOG): 0 or 1
(3)Adequate bone marrow reserves, liver/renal functions:
WBC: >=3500/mm3, =<;12000/mm3
Neutrophil: >=1500/mm3
Platelet: >=100000/mm3
Hb: >=9.5g/dL
AST, ALT, AL-P: less than twofold of the upper limit of normal range
T-Bil: =<1.5mg/dL
Cr: =<1.2mg/dL
CCr: >=50ml/min
PaO2: >=70torr
(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
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Gastroenterological Surgery
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka city, Japan
TEL
+81-6-6972-1181
takahasi-hi@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Gastroenterological Surgery
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka city, Japan
TEL
+81-6-6972-1181
Homepage URL
takahasi-hi@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka Medical Center for Cancer & Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Osaka Medical Center for Cancer & Cardiovascular Diseases
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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 02 | Day |
Last modified on
| 2017 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014580
