UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003052 |
|---|---|
| Receipt number | R000003110 |
| Scientific Title | Phase II study of preoperative Docetaxel, cisplatin and S-1 in patients with clinically respectable type 4 , large type 3 and with extensive lymph node metastasis gastric cancer |
| Date of disclosure of the study information | 2010/01/18 |
| Last modified on | 2021/09/13 20:13:20 |
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Basic information
Public title
Phase II study of preoperative Docetaxel, cisplatin and S-1 in patients with clinically respectable type 4 , large type 3 and with extensive lymph node metastasis gastric cancer
Acronym
A Phase 2 study of preoperative Docetaxel, Cisplatin and S-1 therapy for locally advanced gastric cancer
Scientific Title
Phase II study of preoperative Docetaxel, cisplatin and S-1 in patients with clinically respectable type 4 , large type 3 and with extensive lymph node metastasis gastric cancer
Scientific Title:Acronym
A Phase 2 study of preoperative Docetaxel, Cisplatin and S-1 therapy for locally advanced gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and feasibility of preoperative chemotherapy with Doceraxel, Cisplatin and S-1 for advanced gastric cancer (large type3, type4 or with extensive lymphnode metastasis)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological response
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
Preoperative chemotherapy with Docetaxel, cisplatin and S-1 followed by 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 adenocarcinoma.
2)Macroscopically large Type3 or Type4 gastric cancer or any Type of gastric cancer with massive Lymph-node metastasis
3)No evidence of peritoneal dissemination by diagnostic laparoscopy.(within 4week to entry)
4)Clinically Possible to curative resection.
5)Less than 3cm of esophageal invasion.
6)Age 20-80 years old
7)PS (ECOG) 0-1
8)No prior treatment
9)Sufficient oral intake
10)Adequate organ function
11)Written informed consent
Key exclusion criteria
1)Active malignancy in other organ
2)Serious complications
3)Acute inflammation
4)Allergy or hyper sensitivity to any drugs
5)Motor weakness or peripheral nerve disorder
6)With pleural or cardiac effusion
7)Pregnant or breast feeding
8)Interstitial pneumonia or pulmonary fibrosis
9)Psychological disease which require treatment
10)Hypersensitivity to S1 or CDDP or TXT
11)Systemic administration of other fluorouracil
12)Administration of flucytocine
13)Patients judged inappropriate for the study by the physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Murakami |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2645
airgenzo@gmail.com
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Murakami |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2645
Homepage URL
m_air_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Surgery, Yokohama City 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
Yokohama City University
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
Tel
045-787-2820
rinri@fukuhp.yokohama-cu.ac.jp
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 18 | 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
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 06 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 17 | Day |
Last modified on
| 2021 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003110
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