UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021554 |
|---|---|
| Receipt number | R000024855 |
| Scientific Title | A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/03/22 15:36:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer
Acronym
A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer
Scientific Title
A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer
Scientific Title:Acronym
A feasibility study of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive advanced or recurrent gastric cancer
Region
| Japan |
Condition
Condition
HER2-positive unresectable advanced gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety of combination with oral fluoropyrimidine, oxaliplatin and trastuzumab for HER2-positive unresectable advanced gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
Overall survival, progression-free survival, and response rate
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
Oral fluoropyrimidine (capecitabine or S-1), oxaliplatin and trastuzumab
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
1. Stage IV or recurrence
2. HER2 positive
3. ECOG PS 0-1
4. LVEF>=50% on echo cardiogram
5. Grade 1 or less for diarrhea, stomatitis, hand-foot syndrome, and sensory peripheral nerve neuropathy
6. Laboratory data
1) Neutrophil>=1,500/microl
2) Platelet>=7,500/microl
3) AST<=ULNx2.5(<=ULNx5 if presence of liver metastasis)
4) ALT<=ULNx2.5(<=ULNx5 if presence of liver metastasis)
5) Creatinine clearance>=30 mL/min
Key exclusion criteria
1. HER2 negative
2. Uncontrolled diabetes
3. Uncontrolled hypertension
4. Unstable angina pectoris
5. Synchronous cancers
6. Systemic infection requiring treatment
7. Fever above 38 degree Celsius
8. A possibility of pregnancy or during pregnancy, or lactating women
9. Continuous systemic administration of steroids
10. Resistance to trastuzumab
11. Peripheral neuropathy Grade 2 or more
12. Oxaliplatin allergy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu MAEDA |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-741-2111
maeda-o@med.nagoya-ua.c.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu MAEDA |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-741-2111
Homepage URL
maeda-o@med.nagoya-ua.c.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 01 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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 | 03 | Month | 21 | Day |
Last modified on
| 2016 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024855
