UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003962 |
|---|---|
| Receipt number | R000004769 |
| Scientific Title | Neoadjuvant Chemotherapy for locally advanced gastric cancer with S-1/weekly cisplatin |
| Date of disclosure of the study information | 2010/07/28 |
| Last modified on | 2010/07/28 12:21:15 |
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Basic information
Public title
Neoadjuvant Chemotherapy for locally advanced gastric cancer with S-1/weekly cisplatin
Acronym
Neoadjuvant Chemotherapy for advanced gastric cancer with S-1/weekly cisplatin
Scientific Title
Neoadjuvant Chemotherapy for locally advanced gastric cancer with S-1/weekly cisplatin
Scientific Title:Acronym
Neoadjuvant Chemotherapy for advanced gastric cancer with S-1/weekly cisplatin
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Progress in treatment for advanced gastric cancers - Evaluating antitumor effect, safety and influence on surgical operation of the preoperative dosage of the S-1/weekly cisplatin combination therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Antitumor effect before surgery,
Safety of neoadjuvant chemotherapy,
Safety of surgery after neoadjuvant chemotherapy,
Adverse event during surgical operation
Key secondary outcomes
Histological antitumor effect,
Type of recurrence,
Recurrence-free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Neoadjuvant chemotherapy of S-1/weekly cisplatin
followed by surgical operation
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. Gastric cancer confirmed by histology or cytology
2. Stage II, IIIA or IIIB (T2 or more) by preoperative diagnosis
3. Resectable with surgical operation
4. Tumor lesion able to be measured or evaluated
5. Performance Status (ECOG) 0-1
Key exclusion criteria
1. Suspect of peritoneum dissemination
2. Severe medical condition
3. Active bleeding from gastrointestinal tract
4. Poor oral intake
5. Malignant tumor of other organs
6. Contraindication for S-1 or cisplatin
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachiyo Nomura MD, PhD |
Organization
The University of Tokyo Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Nozaki MD, PhD |
Organization
The University of Tokyo Hospital
Division name
Clinical Research Support Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL
03-3815-5411
Homepage URL
knozaki-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2006 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | 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
| 2010 | Year | 07 | Month | 28 | Day |
Last modified on
| 2010 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004769
