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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024656
Receipt No. 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

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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
Email 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
Email ktaniguchi@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Department of surgery, Institute of Gastroenterology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028365

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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