UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015258 |
|---|---|
| Receipt number | R000017732 |
| Scientific Title | A feasibility study of capecitabine plus oxaliplatin (CapeOX) and S-1 plus oxaliplatin (SOX) for unresectable advanced or reccurent gastric cancer |
| Date of disclosure of the study information | 2014/09/29 |
| Last modified on | 2014/09/26 10:20:48 |
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Basic information
Public title
A feasibility study of capecitabine plus oxaliplatin (CapeOX) and S-1 plus oxaliplatin (SOX) for unresectable advanced or reccurent gastric cancer
Acronym
A feasibility study of capecitabine plus oxaliplatin (CapeOX) and S-1 plus oxaliplatin (SOX) for unresectable advanced or reccurent gastric cancer
Scientific Title
A feasibility study of capecitabine plus oxaliplatin (CapeOX) and S-1 plus oxaliplatin (SOX) for unresectable advanced or reccurent gastric cancer
Scientific Title:Acronym
A feasibility study of capecitabine plus oxaliplatin (CapeOX) and S-1 plus oxaliplatin (SOX) for unresectable advanced or reccurent gastric cancer
Region
| Japan |
Condition
Condition
unresectable advanced or reccurent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of the combination regimen of capecitabine plus oxaliplatin (CapeOX) and S-1 plus oxaliplatin (SOX) in unresectable advanced or reccurent gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
thrombocytopenia, anemia
Key secondary outcomes
neutropenia, sensory neuropathy, anorexia, diarrhea, and relative dose intensity(RDI)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Hematology tests, biochemistry tests, and assesment of symptoms and signs are carried out at the beginning of each treatment cycle. Physical examinations and laboratory studies will be added if needed to evaluate the safety.
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
All patients with unresectable advanced or recurrent gastric cancer, who are going to be treated with oral fluoropyrimidine plus oxaliplatin(i.e.,CapeOX or SOX) will be included. All patients older than 20 years of age are eligible if they have histologically confirmed inoperable locally advanced, recurrent, or metastatic HER-2 negative gastric cancer excluding the esophagus and gastroesophageal junction; Eastern Cooperative Oncology Group(ECOG) performance status 0-2; adequate organ fuction; able to take oral drugs. All patients provide written informed consent.
Key exclusion criteria
Patients are excluded if they have HER-2 postive adenocarcinoma. HER-2 positivity is defined as IHC 3+ or IHC2+ and FISH-positive(HER2:CEP17 ratio over 2). Other exclusion criteria included uncontrolled infection, or uncontrolled significant comorbid conditions.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ando |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8560, Japan
TEL
052-744-1903
yando@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumu Matsuoka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8560, Japan
TEL
052-744-2111
Homepage URL
ayumu0611@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
National University Corporation University Grant
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 09 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 22 | 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
| 2014 | Year | 09 | Month | 26 | Day |
Last modified on
| 2014 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017732
