UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025501 |
|---|---|
| Receipt number | 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 | 2024/01/09 18:55:44 |
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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
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
yamaguchih-tky@umin.net
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
| 2026 | 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
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029350
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| Registered date | File name |
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