UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014332 |
|---|---|
| Receipt number | R000016684 |
| Scientific Title | Phase II study of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for resectable large type 3 or type 4 gastric cancer |
| Date of disclosure of the study information | 2014/06/20 |
| Last modified on | 2019/11/15 09:26:18 |
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Basic information
Public title
Phase II study of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for resectable large type 3 or type 4 gastric cancer
Acronym
Phase II study of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for advanced gastric cancer
Scientific Title
Phase II study of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for resectable large type 3 or type 4 gastric cancer
Scientific Title:Acronym
Phase II study of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for advanced gastric cancer
Region
| Japan |
Condition
Condition
Advanced gastric cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the efficacy and safety of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for highly advanced gastric cancer (resectable large type 3 or type 4).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year overall survival
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 | Maneuver |
Interventions/Control_1
Neoadjuvant chemotherapy
TS-1: 80mg/m2 Day 1-14
CDDP: 20mg/m2 Day 1, 15
Paclitaxel: 100mg/m2 Day 1, 15
Surgery should be performed after 2 courses of neoadjuvant chemotherapy.
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) adenocarcinoma of the stomach
2) Macroscopically either large Type 3 (more than 8cm)or 4
3) Without neither liver nor pritoneal metastasis
4) The invasion to esophagus is within 3cm.
5) Age: From 20y.o to 75 y.o.
6) ECOG PS 0 or 1
7) No prior treatment
8) Possible oral intake
9) Sufficient function of important organs
10) written informed consent
Key exclusion criteria
1) with severe drug allergy
2) with highly lymph node metastases
3) with severe infection
4) with severe diarrhea
5) with severeintestinal paralysis or ileus
6) with interstitial pneumonia or pulmonary fibrosis
with other active malignant disease
7) with active other malignancy
8) with severe diabetes
9 ) with severe heart disease
10) pregnant or nursing women or women who like be pregnant and willing to get pregnant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kitagawa Yuko |
Organization
School of Medicine, Keio University
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-3353-1211
kitagawa@a3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsunehiro Takahashi |
Organization
School of Medicine, Keio University
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
tsunehiro-t@a8.keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Keio University
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
| 2014 | Year | 06 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016684
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