UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000857 |
|---|---|
| Receipt number | R000001029 |
| Scientific Title | Docetaxel and S-1 as adjuvant chemotherapy for pathological stage II, IIIA, IIIB gastric cancer |
| Date of disclosure of the study information | 2007/10/19 |
| Last modified on | 2010/11/19 08:33:48 |
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Basic information
Public title
Docetaxel and S-1 as adjuvant chemotherapy for pathological stage II, IIIA, IIIB gastric cancer
Acronym
Docetaxel and S-1 as adjuvant chemotherapy
Scientific Title
Docetaxel and S-1 as adjuvant chemotherapy for pathological stage II, IIIA, IIIB gastric cancer
Scientific Title:Acronym
Docetaxel and S-1 as adjuvant chemotherapy
Region
| Japan |
Condition
Condition
Pathological stage II, IIIa, or IIIb gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility of Docetaxel + S-1 as adjuvant chemotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Feasibility of Docetaxel+S-1 4 cycles
Key secondary outcomes
Feasibility of Docetaxel+S-1 4 cycles followed by S-1 alone for 1 year,
Safety
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(40mg/m2, day1), S-1(80mg/m2, day1-14) combination therapy, every 3 weeks, 4 cycles followed by S-1(80mg/m2, day1-14) monotherapy every 3 weeks until 1 year from 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed Gastric cancer
2. Curatively resected gastric cancer(R0 surgery) with D2 lymph-node resection
3. Pathlogical Stage II, IIIA, IIIB
4. No prior chemotherapy for current disease.
5. Sufficient organ function (within 2 weeks before enrollment)
6. ECOG performance status 0-1.
7. Age ≥20 and <80 years old
8. Maximum of 8 weeks since surgery and patients who can take medicine orally.
9. Written informed consent.
Key exclusion criteria
1. 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.
2. Contraindication to S-1
3. Under treatment with flucytosine, phenytoin, or warfarin
4. Past history of severe drug hypersensitivity.
5. Uncontrolled medical conditions (e.g., Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray, malignant hypertension, congestive heart failure, myocardial infarction in previous 6 months, arrhythmia requiring treatment, hemorrhage, diabetes).
6. Hepatitis B/C
7. Diarrhea
8. Pregnant or lactating women and women of child bearing potential not using contraception
9. Severe peripheral edema.
10. Grade 2 or greater peripheral neuropathy.
11. HIV positive.
12. Patients judged by the investigator as unfit to be enrolled in the study.
Target sample size
20
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 | 10 | Month | 19 | 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
| 2007 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 18 | Day |
Last modified on
| 2010 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001029
