UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024656 |
|---|---|
| Receipt number | R000028365 |
| Scientific Title | A prospective intervention study on the availability of the preoperative SOX therapy for the T4 or N2-3 gastric cancer |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2016/10/31 19:14:21 |
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Basic information
Public title
A prospective intervention study on the availability of the preoperative SOX therapy for the T4 or N2-3 gastric cancer
Acronym
A prospective intervention study on the availability of the preoperative SOX therapy for the T4 or N2-3 gastric cancer
Scientific Title
A prospective intervention study on the availability of the preoperative SOX therapy for the T4 or N2-3 gastric cancer
Scientific Title:Acronym
A prospective intervention study on the availability of the preoperative SOX therapy for the T4 or N2-3 gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In cT4 or N2-3M0 of advanced gasiriccancer, we examine availability of the gastrectomy after 2 cycles of preoperative SOX (S-1 and oxaliplatin) therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of R0 resection,
Key secondary outcomes
3-year relapse-free survival,
3-year overall survival,
5-year relapse-free survival,
5-year overall survival,
Response Rate,
Pathological response rate,
Percent completion of neoadjuvant chemotherapy,
Incidence of adverse events on neoadjuvant chemotherapy,
Incidence of a postoperative complication,
proportion of protocol achievement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preoperative chemotherapy with S-1 (80-120 mg/body, p.o., day 1-14) plus oxaliplatin (130 mg/m2, IV, day 1,) for 2cycles followed by gastrectomy with D2 lymph node dissection and postoperative chemotherapy with S-1 or XELOX.
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. Patients in Tokyo Women's Medical University Hospital.
2.Histologically proven gastric adenocarcinoma
3. Clinical T4a,4b(SE,SI) by imaging gastric cancer or enlarged lymph nodeby computed tomography.
4.No distatnt metastasis based on thoracic,abdominal,pelvic CT and staging laparoscopy is performed before registration, non-curable factors other than positive lavage cytology are not revealed.
5. No esophageal invasion or an invasion of 3 cm or less.
6. Age between 20 and 80 years old
7. Eastern Cooperative Oncology Group performance status of 0 or 1.
8. No bleeding from primary lesions nor obstruction.
9. Possible oral intake
10. Adequate organ function
11. Written informed consent from patient
Key exclusion criteria
1) Past history of severe hypersensitivity to drugs
2) Severe complications
3) The patients with
4) Infectious disease requiring systemic treatment.
5) Poorly controlled hypertention.
6) Poorly controlled diabetes.
7) History of unstable angina pectoris or myocardial infarction within 12 months before registration.
8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
9) Uncontrolled psychiatry disease.
10) Peripheral sensory neuropathy of grade >= 2 .
11) Synchronous or metachronous (within 5 years) malignancies
12) Under treatment with flucytosine, phenytoin, or warfarin.
13) The patients who are pregnant women, or women with the
possibility of the pregnancy.
14) Severe mental disease.
15) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
16) Massive pleural effusion or ascites
17) Active gastrointestinal tract bleeding requiring repeated transfusions.
18) Positive HIV antigen or positive HBs antigen
19) Patients judged inappropriate for the study by the physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Yamamoto |
Organization
Tokyo Women's Medical University
Division name
Departmentof surgery,Institute of Gastroenterology
Zip code
Address
8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
ktaniguchi@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoaki Taniguchi |
Organization
Tokyo Women's Medical University
Division name
Department of surgery, Institute of Gastroenterology
Zip code
Address
8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Homepage URL
ktaniguchi@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Department of surgery, Institute of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Department of surgery, Institute of Gastroenterology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Women's Medical University
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 31 | Day |
Last modified on
| 2016 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028365
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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