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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017084
Receipt No. R000019819
Scientific Title Phase I study of intraperitoneal docetaxel and irinotecan for advanced gastric cancer with peritoneal metastasis
Date of disclosure of the study information 2015/04/09
Last modified on 2017/07/12

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Basic information
Public title Phase I study of intraperitoneal docetaxel and irinotecan for advanced gastric cancer with peritoneal metastasis
Acronym Phase I study of CPT+IP DOC
Scientific Title Phase I study of intraperitoneal docetaxel and irinotecan for advanced gastric cancer with peritoneal metastasis
Scientific Title:Acronym Phase I study of CPT+IP DOC
Region
Japan

Condition
Condition gastric cancer with peritoneal metastasis
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and determine the recommended dose of intraperitoneal docetaxel and irinotecan
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes safety
Key secondary outcomes negative conversion rate on peritoneal cytology

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 intraperitoneal docetaxel and intravenous irinotecan
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 Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal metastasis; age between 20 and 75 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >9.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <2.0 mg/dl, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); and an expected survival period of more than 3 months.
Key exclusion criteria Other active concomitant malignancies, massive ascites or other severe medical conditions.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironori Ishigami
Organization The University of Tokyo
Division name Department of Chemotherapy
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email ishigami-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Hironori Ishigami
Organization The University of Tokyo
Division name Department of Chemotherapy
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email ishigami-tky@umin.net

Sponsor
Institute 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
2015 Year 04 Month 09 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
2015 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 23 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
2015 Year 04 Month 09 Day
Last modified on
2017 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019819

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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