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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025501
Receipt No. R000029350
Scientific Title Exploratory study of adverse events at the unexperienced hospital in the treatment for gastric cancer with peritoneal metastasis with intraperitoneal paclitaxel combined with S-1 plus oxaliplatin
Date of disclosure of the study information 2017/02/28
Last modified on 2019/07/08

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Basic information
Public title Exploratory study of adverse events at the unexperienced hospital in the treatment for gastric cancer with peritoneal metastasis with intraperitoneal paclitaxel combined with S-1 plus oxaliplatin
Acronym Exploratory study of adverse events in SOX+IP PTX for peritoenal metastasis of gastric cancer
Scientific Title Exploratory study of adverse events at the unexperienced hospital in the treatment for gastric cancer with peritoneal metastasis with intraperitoneal paclitaxel combined with S-1 plus oxaliplatin
Scientific Title:Acronym Exploratory study of adverse events in SOX+IP PTX for peritoenal metastasis of gastric cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety of intraperitoneal paclitaxel combined with S-1 plus oxaliplatin in gastric cancer patients with peritoneal metastasis at the the unexperienced hospital.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes safety
Key secondary outcomes 1-year overall survival
response rate
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 PTX is administered intraperitoneally at 40 mg/m2 on days 1 and 8.
S-1 is administered at 80 mg/m2/day for 14 consecutive days, followed by 7 days rest.
Oxaliplatin is administered at 100 mg/m2 on day1.
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 and/or cancer cells on peritoneal cytology; age more than 20 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <1.5 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 Metastasis to distant organ sites (such as the liver, lungs or bone), other active concomitant malignancies, or other severe medical condition.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hironori
Middle name
Last name Yamaguchi
Organization Jichi Medical University
Division name Department of Clinical Oncology
Zip code 329-0498
Address 3311-1 Yakushiji Shimotsukeshi Tochigi
TEL 0285-44-2111
Email yamaguchih-tky@umin.net

Public contact
Name of contact person
1st name Hironori
Middle name
Last name Hironori
Organization Jichi Medical University
Division name Department of Clinical Oncology
Zip code 329-0498
Address 3311-1 Yakushiji Shimotsukeshi Tochigi
TEL 0285-44-2111
Homepage URL
Email yamaguchih-tky@umin.net

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Self funding
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 Jichi medical university clinical research support center
Address 3311-1 Yakushiji Shimotsukeshi Tochigi
Tel 0285-58-8933
Email shien@jichi.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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 28 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 12 Day
Date of IRB
2017 Year 05 Month 10 Day
Anticipated trial start date
2017 Year 05 Month 29 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 03 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029350

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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