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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006385
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Nihon Medical School Musasikosugi Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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