UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024148
Receipt number 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 2023/01/04 08:28:48

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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 Yousuke
Middle name
Last name Nakai

Organization

The University of Tokyo

Division name

Department of Gastroenterology

Zip code

113-8655

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 Namianstu
Middle name
Last name Takahara

Organization

The University of Tokyo

Division name

Department of Gastroenterology

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL


Email

naminatsu-takahara@umin.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, The University of Tokyo

Institute

Department

Personal name



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

The University of Tokyo, Clinical Research Review Board

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.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



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

No longer recruiting

Date of protocol fixation

2016 Year 08 Month 26 Day

Date of IRB

2016 Year 10 Month 30 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2024 Year 06 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

2016 Year 09 Month 24 Day

Last modified on

2023 Year 01 Month 04 Day



Link to view the page

Value
https://center6.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