UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000875 |
|---|---|
| Receipt number | R000001046 |
| Scientific Title | Phase II study of docetaxel and S-1 as neoadjuvant chemotherapy + gastrectomy for cStage IIIa-IIIb(IV) resectable gastric cancer |
| Date of disclosure of the study information | 2007/11/05 |
| Last modified on | 2009/10/28 12:44:50 |
* 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
Phase II study of docetaxel and S-1 as neoadjuvant chemotherapy + gastrectomy for cStage IIIa-IIIb(IV) resectable gastric cancer
Acronym
Docetaxel and S-1 as neoadjuvant chemothrapy for resectable gastric cancer
Scientific Title
Phase II study of docetaxel and S-1 as neoadjuvant chemotherapy + gastrectomy for cStage IIIa-IIIb(IV) resectable gastric cancer
Scientific Title:Acronym
Docetaxel and S-1 as neoadjuvant chemothrapy for resectable gastric cancer
Region
| Japan |
Condition
Condition
clinical stage IIIa-IIIb(IV) gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of docetaxel and S-1 as neoadjuvant chemotherapy for patients with stage IIIa, IIIb or IV (cT4N2) gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological response
Key secondary outcomes
Response rate of neoadjuvant chemotherapy
Treatment completion rate
Complete resection rate
3 year relapse free survival
3 year overall survival
Adverse events
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 35 mg/m2 1-hour IV days 1,15
S-1 80 mg/m2 PO BID days 1-14,
every 28 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,
CY0, P0, H0 by laparoscopy,
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
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Maehara |
Organization
Kyushu University
Graduate School of Medical Sciences
Division name
Dept. of Surgery and Science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan 812-8582
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Kakeji |
Organization
Kyushu University
Division name
Dept. of Surgery and Science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan 812-8582
TEL
Homepage URL
Sponsor or person
Institute
Dept. of Surgery and Science, Kyushu University
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | 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
| 2007 | Year | 11 | Month | 02 | Day |
Last modified on
| 2009 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001046
