UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022861 |
|---|---|
| Receipt number | R000026251 |
| Scientific Title | Phase I trial of capecitabine, oxaliplatin and irinotecan combination chemotherapy (XELOXIRI) for advanced gastric cancer |
| Date of disclosure of the study information | 2016/06/24 |
| Last modified on | 2018/12/28 12:51:15 |
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Basic information
Public title
Phase I trial of capecitabine, oxaliplatin and irinotecan combination chemotherapy (XELOXIRI) for advanced gastric cancer
Acronym
Phase I trial of XELOXIRI for advanced gastric cancer
Scientific Title
Phase I trial of capecitabine, oxaliplatin and irinotecan combination chemotherapy (XELOXIRI) for advanced gastric cancer
Scientific Title:Acronym
Phase I trial of XELOXIRI for advanced gastric cancer
Region
| Japan |
Condition
Condition
Advanced gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine recommended dose of capecitabine, oxaliplatin, irinotecan combination chemotherapy (XELOXIRI)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose limiting toxicity
Key secondary outcomes
objective response rate
disease control rate
adverse event
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
Combination chemotherapy with capecitabine, oxaliplatin and irinotecan. Oxaliplatin and irinotecan are administered on day1. Capecitabine is taken orally from day1 to day14. Increasing dose of irinotecan is administered when patients with dose limiting toxicity were fewer than the criteria.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven advanced / recurrent gastric cancer
2) Possible for oral intake and medication
3) Evaluable legions
4) No history of chemotherapy, immunotherapy or radiotherapy
5) ECOG performance status 0 or 1
6) No major complications
7) Written informed consent
Key exclusion criteria
1) HER2 positive
2) UGT1A1 *6 or *28 homozygote or *6 and *28 heterozygote
3) Symptomatic brain metastasis
4) Infectious disease
5) Grade 2 or more diarrhea
6) Grade 2 or more peripheral sensory neuropathy
7) Massive pleural effusion, ascites, or cardiac effusion
8) Ileus
9) Defined interstitial pneumonia
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eishi Baba |
Organization
Kyushu University Faculty of Medical Sciences
Division name
Department of Conprehensive Clinical Oncology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city, Japan
TEL
092-642-6921
e-baba@intmed1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Tamura |
Organization
Kyushu Medical Center
Division name
Department of Clinical Oncology
Zip code
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka city, Fukuoka, Japan
TEL
092-852-0700
Homepage URL
tamshin@me.com
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 06 | Month | 24 | 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
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 27 | 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
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026251
