UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002685 |
|---|---|
| Receipt number | 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 17:49:41 |
* 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 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
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
sokazaki@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003278
