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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024148
Receipt No. R000027806
Scientific Title A phase I/II study of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis
Date of disclosure of the study information 2017/01/01
Last modified on 2018/08/18

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Basic information
Public title A phase I/II study of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis
Acronym Phase I/II study of GnP + IP PTX
Scientific Title A phase I/II study of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis
Scientific Title:Acronym Phase I/II study of GnP + IP PTX
Region
Japan

Condition
Condition pancreatic cancer patients with peritoneal metastasis
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I ; Dose limiting toxicity
Phase II; Overall survival
Key secondary outcomes Phase I ; Safety
Phase II; Response rate, Progression-free survival, Negative conversion rate on peritoneal cytology, Safety

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 intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel on days 1, 8 and 15 every 28 days
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) histologically or cytologically proven pancreatic adenocarcinoma
2) No previous antitumorcancer treatment other than surgery and adjuvant chemotherapy
3) peritoneal metastasis confirmed by diagnostic imaging, staging laparoscopy or laparotomy within 14 days before registration
4) adequate organ functions(according to the laboratory data which was taken within 7 days before registration)
5) Eastern Cooperative Oncology Group performance status 0-1
6) oral intake
7) written informed consent
Key exclusion criteria 1) contraindication for gemcitabine, nab-paclitaxel or paclitaxel
2) other active concomitant malignancies
3) allergy to iodine or gadolinium contrast agent
4) Blood transfusion or usege of G-CSF within 7 days before enrollment
5) past or current severe heart disease, liver cirrhosis, active GI ulcers or obstruction
6) severe complications such as interstitial pneumonitis, pulmonary fibrosis
7) uncontrollable diabetes mellitus
8) grade 3/4 of sensory neuropathy
9) active infection rather than HBV/HCV
11) pregnant or nursing women
12) judged to be unfit to participate in this study by investigators
Target sample size 53

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-+3815-5411
Email isayama-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naminatsu Takahara
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email naminatsu-takahara@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, The University of Tokyo
Institute
Department

Funding Source
Organization The University of Tokyo
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 01 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 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
2016 Year 09 Month 24 Day
Last modified on
2018 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027806

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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