UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001401 |
|---|---|
| Receipt number | R000001703 |
| Scientific Title | Phase II study of S-1 and CDDP as neoadjuvant chemotherapy for patients with lymph node metastasis from resectable gastric cancer |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2014/07/16 12:21:48 |
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Basic information
Public title
Phase II study of S-1 and CDDP as neoadjuvant chemotherapy for patients with lymph node metastasis from resectable gastric cancer
Acronym
CDDP+S-1 as neoadjuvant chemotherapy for resecatbele lymph node metastatic gastric cancer
Scientific Title
Phase II study of S-1 and CDDP as neoadjuvant chemotherapy for patients with lymph node metastasis from resectable gastric cancer
Scientific Title:Acronym
CDDP+S-1 as neoadjuvant chemotherapy for resecatbele lymph node metastatic gastric cancer
Region
| Japan |
Condition
Condition
Resecatbele lymph node metastatic gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of CDDP and S-1 as neoadjuvant chemotherapy for patients with lymph node metastasis from gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Complete resection rate
Key secondary outcomes
Compliance of treatment tolerance
Response rate
Relapse Free Survival (3years)
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
CDDP 60 mg/m2 one-hour days 8, S-1 80 mg/m2 PO days 1-21, every 35 days for 2 cycles followed by gastrectomy with D2 lymph node dissection
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically or cytologically confirmed adenocarcinoma of the stomach,
curative resection possible by total body computed tomography (CT) scan.
Age 20-80 years old,
No prior therapy including surgery, radiotherapy or chemotherapy for current disease,
patients who can take medication orally,
ECOG performance status 0-1,
Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions, Written informed consent.
Key exclusion criteria
A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix,
patients contraindicated to S-1,
A history of severe drug hypersensitivity,
Uncontrolled medical conditions , Documented or suspected infection, Patients requiring treatment with corticosteroids except for pre-medication,
Hepatitis B or C,
patients with diarrhea,
Pregnant or lactating women and women of child bearing potential not using contraception,
Severe psychiatric disorders,
Severe edema,
Grade 2 or grater peripheral neuropathy,
HIV positive,
patients judged by the investigator as unfit to be enrolled in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsugu Kochi |
Organization
Nihon University School of Medicine
Division name
Department of Digestive Surgery
Zip code
Address
30-1 Ohyaguchi Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
kochi.mitsugu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsugu Kochi |
Organization
Nihon University School of Medicine
Division name
Department of Digestive Surgery
Zip code
Address
30-1 Ohyaguchi Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
kochi.mitsugu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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
日本大学医学部附属板橋病院(東京都）
Nihon University School of Medicine Itabashi Hospital（Tokyo)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
| 2002 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 29 | Day |
Last modified on
| 2014 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001703
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| Registered date | File name |
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