UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011625 |
|---|---|
| Receipt number | R000013599 |
| Scientific Title | Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer |
| Date of disclosure of the study information | 2013/09/02 |
| Last modified on | 2017/09/06 15:25:22 |
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Basic information
Public title
Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer
Acronym
Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer
Scientific Title
Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer
Scientific Title:Acronym
Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish neoadjuvant chemotherapy with high safty and usefullness for stage III gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I : Feasibility of the regimen followed by decision of recommend dose
Phase II : Response rate, Overall survival, Adverse events
Key secondary outcomes
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
Docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy
Docetaxel: 20mg/m2 day1,15
CDDP: 25-50mg/m2 day1,15
TS-1: 80mg/m2 day1-7, 15-21
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
1. Histologic confirmation of gastric cancer
2. Stage III with no peritoneal meastases and CY0 by dagnostic laparoscopy
3. Patient expected R0 resection at the registration
4. Performance status (ECOG scale) 0 or 1
5. No prior chemotherapy
6. Adequate baseline organ and marrow function from data within 14 days before registration
WBC count >=3,000/mm3,<=12,000/mm3
Neutorophil count>=1,500/mm3
Hemoglobin>=9.0g/dl
Platelet count>=100000/mm3
AST,ALT<= 2.5 times the upper limit of normal
Al-P<=2.5 times the upper limit of normal
Total bilirubin<=1.5 mg/dl
serum creatinin level<=1.5 mg/dl
Blood urea nitrogen within normal range
7. Patients who can take food orally
8. Provision of written informed consent
Key exclusion criteria
1. with active double cancer within 5 years except intramucosal cancer
2. with a history of severe allergy
3. with active infectious disease(over 38 degrees C)
4. Women in pregnancy, at risk of pregnancy, or hoping to become pregnant.
5. Men who want their partners to become pregnant
6. with a history of cardiac infarction in recent 6 months
7. with a continuous administration of steroids
8. patient who needs continuous administration of Flucytosine, fenitoin or walfarin karium
9. with ulceration on digestive tract and/or bleeding from the ulcer
10. with uncontrollable diarrhea or watery stool
11. with active hepatitis B Ag and/or hepatitis C Ab
12. with serious complication as followings,
-Interstitial pneumonia
-Pulmonary fibrosis
-paralysis on bowel
-ischemic heart diseases
13. Any patients judged by the investigator to be unfit to participate in the study
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikara Kunisaki |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
s0714@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Izumisawa |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
ycu.umin@gmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 02 | 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
| 2010 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 02 | Day |
Last modified on
| 2017 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013599
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