UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005600 |
|---|---|
| Receipt number | R000006619 |
| Scientific Title | Feasibility stuydy of S-1 and weekly cisplatin in patients received R0 resection for Stage IIB and III gastric cancer |
| Date of disclosure of the study information | 2011/05/15 |
| Last modified on | 2016/07/20 22:10:21 |
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Basic information
Public title
Feasibility stuydy of S-1 and weekly cisplatin in patients received R0 resection for Stage IIB and III gastric cancer
Acronym
Feasibility study of S-1 and weekly cisplatin in patients recieved R0 resection gastric cancer.
Scientific Title
Feasibility stuydy of S-1 and weekly cisplatin in patients received R0 resection for Stage IIB and III gastric cancer
Scientific Title:Acronym
Feasibility study of S-1 and weekly cisplatin in patients recieved R0 resection gastric cancer.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility and safety of adjuvant treatment with a combination of S-1 plus weekly CDDP in patients with gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Treatment compliance with proportion of patients receiving 4 courses of Adjuvant treatment according to protocol
Key secondary outcomes
Adverse Event, Overall survival,
Disease-free survival, and Relapse-free survival
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
At the first course of adjuvant chemotherapy, only S-1 is administered for 28 days followed by 14 days rest.
At the 2 - 4 course, S-1 plus CDDP adjuvant chemotherapy is conducted.
After 5 course, S-1 is conducted for 6 weeks until 1 year after surgery.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically proved adenocarcinoma of stmach
2) >= D2 lymphnode dissection, curability A(R0)
3) Stage IIB/III/IIIB/IIIC (Japanese classification)
4) Age between 20 and 75
5) No prior chemotherapy or radiotherapy
6) Able to started of treatment between 8 weeks after surgery
7) ECOG performance status 0-1
8) With ability of oral intake
9) Patients have enough organ function for study treatment
Hemoglobin >9.0g.dl
WBC 3,500/mm3< <12,000/mm3
Neutrophil > 2,000/mm3
Platelets >100,000/mm3
Total bilirubin <1.5mg/dl
AST and ALT < 100IU
Ccr > 60ml/min
10) Written informed consent
Key exclusion criteria
1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2) administration contraindication to S-1 and CDDP
3) systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
4) with active infection
5) with drug hypersensitivity
6) other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis)
7) with water solubility diarrhea
8) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant
9) men with willing to get pregnant
10)Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Konno |
Organization
Hamamatsu University School of Medicine
Division name
Second Department of Surgery
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan
TEL
053-435-2279
otam@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Otha |
Organization
Hamamatsu University School of Medicine
Division name
Hamamatsu University School of Medicine
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan
TEL
053-435-2279
Homepage URL
otam@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu Organization for Oncology Research and Education : HORE
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Organization for Oncology Research and Education : HORE
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
浜松医科大学（静岡県）
県西部浜松医療センター（静岡県）
磐田市立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 13 | Day |
Last modified on
| 2016 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006619
