UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018658
Receipt number R000021585
Scientific Title Phase I study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 and intraperitoneal infusion of nafamostat mesilate for gastric cancer with peritoneal dissemination
Date of disclosure of the study information 2015/09/01
Last modified on 2021/02/14 14:03:24

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Basic information

Public title

Phase I study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 and intraperitoneal infusion of nafamostat mesilate for gastric cancer with peritoneal dissemination

Acronym

Phase I study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 and intraperitoneal infusion of nafamostat mesilate for gastric cancer with peritoneal dissemination

Scientific Title

Phase I study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 and intraperitoneal infusion of nafamostat mesilate for gastric cancer with peritoneal dissemination

Scientific Title:Acronym

Phase I study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 and intraperitoneal infusion of nafamostat mesilate for gastric cancer with peritoneal dissemination

Region

Japan


Condition

Condition

Gastric cancer with peritoneal dissemination

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safity and toxicity of the treatment with PTX/S-1/FUT175 and to determine the MTD and RD

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

To evaluate the safety and determine RD

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

Paclitaxel is administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8. Nafamostat mesilate is administered intraperitoneally with an initial dose of 40 mg/body, stepped up to 60 or 80 mg/body. S-1 is administered at 80 mg/m2/day for 14 consecutive days, followed by 7 days rest. The cycle is repeated every 3 weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal dissemination and/or cancer cells on peritoneal cytology; age more than 20 years; Eastern Cooperative Oncology Group performance status 0-1; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >= 8.0 g/dl, platelets >= 100,000/mm3 ); adequate liver function (AST/ALT </= 100, total bilirubin </=2.0 mg/dL); adequate renal function(BUN </= 1.0 x ULN, serum creatinine </= 1.2mg/dL, creatinine clearance>= 60 ml/min), adequate oral intake, and an expected survival period of more than 3 months.

Key exclusion criteria

Metastasis to distant organ sites (such as the liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions (such as pulmonary fibrosis, active infection, uncontrollable heart disease, uncontrollable diabetes mellitus, history of severe drug allergy).

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norio Mitsumori

Organization

The Jikei University School of Medicine

Division name

Division of Gastrointestinal surgery, Department of Surgery

Zip code


Address

3-25-8, Nishi-shinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Email

mitsumori@jikei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norio Mitsumori

Organization

The Jikei University School of Medicine

Division name

Division of Gastrointestinal surgery, Department of Surgery

Zip code


Address

3-25-8, Nishi-shinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Homepage URL


Email

mitsumori@jikei.ac.jp


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Surgery, The Jikei University School of Medicine

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

2015 Year 09 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

Terminated

Date of protocol fixation

2013 Year 11 Month 01 Day

Date of IRB

2013 Year 11 Month 01 Day

Anticipated trial start date

2013 Year 11 Month 01 Day

Last follow-up date

2019 Year 03 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 12 Day

Last modified on

2021 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021585


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name