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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002685
Receipt No. R000003278
Scientific Title Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients
Date of disclosure of the study information 2009/10/29
Last modified on 2010/05/04

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Basic information
Public title Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients
Acronym Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients
Scientific Title Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients
Scientific Title:Acronym Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of outpatient chemotherapy with S-1+CDDP in patients with unresectablly advanced, recurrent gastric cancer or advanced gastric cancer patients who require neoadjuvant chemotherapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Completion proportion of 2 cycles in outpatient arm
Key secondary outcomes Completion proportion of 2 cycles in inpatient arm, completion proportion of 2 cycles in all patients, progression free survival, proportion of incidence of adverse events in outpatient arm, inpatient arm, and all patients

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1+CDDP therapy (S-1 80-120 mg day 1-21, CDDP 60 mg/m2 day 8) was repeated until the completion of 2 cycles every 5 weeks in unresectablly advanced, recurrent gastric cancer, and every 4 weeks in advanced gastric cancer patients who require neoadjuvant chemotherapy.
Recruited patients take oral hydration test over days 1-7 of the 1st cycle, and are allocated to outpatient arm when oral hydration is adequate, or to inpatient arm when inadequate.
In outpatient arm, patients are administered intravenous hydration only on day 8, and are encouraged to take oral hydration >=1.5 L on days 9-10 of each cycle, and they take antiemetics orally on days 9-11, and they also take diuretics orally as needed.
Interventions/Control_2 In inpatient arm, patients are administered intravenous hydration on days 8-10 of each cycle.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Unresectablly advanced, recurrent gastric cancer patients or advanced gastric cancer who require neoadjuvant chemotherapy.
2) Histologically confirmed primary gastric cancer.
3) Performance status (ECOG) of 0, 1, or 2.
4) Age between 20 and 75 years.
5) Estimated to be able to take oral hydration >=1.5L/day.
6) Adequate organ function confirmed by laboratory data below (within 2 weeks before registration).
Neutrophil >=1200/mcl
Hb >=8.0g/dl
Plt >=75000/mcl
T-Bil <=3.0mg/dl
GOT <=100IU/l
GPT <=100IU/l
Cr <=1.5mg/dl or estimated Ccr >=50ml/min
7) Written informed consent.
Key exclusion criteria 1) History of hypersensitivity to S-1 or CDDP.
2) Receiving fluoropyrimidine preparation.
3) Receiving systemic steroid therapy.
4) Required to continue to take flucytosine, phenytoin, and warfarin.
5) Severe complications (ileus, bowel obstruction, interstitial lung disease, uncontrolled diabetes, severe arrhythmia, heart failure, renal failure, liver cirrhosis, active hepatitis, and so on).
6) Active ischemic heart disease.
7) Woman who are pregnant, lactating, or willing to get pregnant, or man who are willing to have unprotected intercourse.
8) Severe mental disorder.
9) Regarded as inadequate physical conditions by attending physician.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takako Nakajima
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3541-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Okazaki
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email sokazaki@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Aichi Cancer Center Hospital
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 国立がんセンター中央病院(東京都)、愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 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 Completed
Date of protocol fixation
2008 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 29 Day
Last modified on
2010 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003278

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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