UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006385 |
|---|---|
| Receipt number | R000007577 |
| Scientific Title | Feasibility study of outpatient chemotherapy with Capecitabine plus fractional Cisplatin for Advanced or Recurrent Gastric Cancer |
| Date of disclosure of the study information | 2011/09/22 |
| Last modified on | 2012/10/05 09:24:28 |
* 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
Feasibility study of outpatient chemotherapy with Capecitabine plus fractional Cisplatin for Advanced or Recurrent Gastric Cancer
Acronym
Feasibility study of outpatient chemotherapy with Capecitabine plus fractional Cisplatin
Scientific Title
Feasibility study of outpatient chemotherapy with Capecitabine plus fractional Cisplatin for Advanced or Recurrent Gastric Cancer
Scientific Title:Acronym
Feasibility study of outpatient chemotherapy with Capecitabine plus fractional Cisplatin
Region
| Japan |
Condition
Condition
Patients with unresctable or recurrent gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and to determine recommended dose of outpatient chemotherapy with Capecitabine plus fractional Cisplatin for Advanced or Recurrent Gastric Cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety [Incidence of dose limiting toxicity]
Determine recommend dose
Key secondary outcomes
Progression free survival
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Capecitabine plus fractional Cisplatin
Level 1
Capecitabine:2000mg/m2/day p.o.(day1-14)+Cisplatin:30mg/m2 i.v.(day1,8) to be repeated every 3 weeks.
Cisplatin is stepped up to 40mg/ m2.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histological and pathological confirmation of advanced or recurrent gastric adenocarcinoma.
2.Patient who are possible to be orally administrated.
3.Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 - 1.
4.Life expectancy estimate 2 months, and more.
5.Adequate organ functions
6.Written informed consent.
Key exclusion criteria
1.Pregnant or breast-feeding women were excluded
2.Clinically significant cardiovascular disease
3.Evidence of central nervous system metastases
4.Major surgery or trauma in previous 4 weeks.
5.Inappropriate for this study judged by the attending physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Suzuki |
Organization
Nihon Medical School Musasikosugi Hospital
Division name
Digestive Disease Center
Zip code
Address
1-396 Kosugicho, Nakahara-ku, Kawasaki-city, 211-8533, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Bou |
Organization
Nihon Medical School Musasikosugi Hospital
Division name
Digestive Disease Center
Zip code
Address
1-396 Kosugicho, Nakahara-ku, Kawasaki-city, 211-8533, Japan
TEL
044-733-5181
Homepage URL
Sponsor or person
Institute
Nihon Medical School Musasikosugi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2011 | Year | 09 | Month | 22 | 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
| 2011 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | 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
| 2011 | Year | 09 | Month | 21 | Day |
Last modified on
| 2012 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007577
