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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007589
Receipt No. R000008929
Scientific Title A feasibility study of neoadjuvant Oxaliplatin and S-1 for clinical T3 or T4 gastric cancer
Date of disclosure of the study information 2012/03/31
Last modified on 2016/03/28

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Basic information
Public title A feasibility study of neoadjuvant Oxaliplatin and S-1 for clinical T3 or T4 gastric cancer
Acronym A feasibility study of neoadjuvant Oxaliplatin and S-1 for clinical T3 or T4 gastric cancer
Scientific Title A feasibility study of neoadjuvant Oxaliplatin and S-1 for clinical T3 or T4 gastric cancer
Scientific Title:Acronym A feasibility study of neoadjuvant Oxaliplatin and S-1 for clinical T3 or T4 gastric cancer
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to evaluate the safety of neoadjuvant Oxaliplatin and S-1 for clinical T3 or T4 gastric cancer patients.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes proportion of protocol completion
Key secondary outcomes overall survival, relapse-free survival,response rate, pathological response rate,adverse events, operative morbidity, treatment related death

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 Oxaliplatin and S-1 followed by gastrectomy with D2 lymph node dissection
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven primary gastric adenocarcinoma.
2) Upper GI endoscopy and enhanced abdominal CT revealed having T3 or T4 tumor.
3) Enhanced CT revealed having no distant metastasis. No peritoneal metastasis and CY0 by laparoscopy.
4) Age between 20 and 75 at registration.
5) Performance Status(ECOG) 0 or 1.
6) No prior treatment of chemotherapy nor radiation therapy nor endocrine therapy against any other malignancies. No prior surgery for gastric carcinoma.
7) No bleeding from primary lesions nor obstruction.
8) Fair oral intake with or without bypass surgery.
9) CT revealed no interstitial pneumonia, pulmonary fibrosis, nor severe emphysema.
10) Adequate organ functions defined as indicated below;
i) WBC >= 3,000/mm3 and <=12,000/mm3.
ii) Hb >= 9.0 g/dL.
iii) Platelet >= 100,000/mm3.
iv) AST <= 50 IU/L.
v) ALT <= 50 IU/L.
vi) T.Bil <= 1.5 mg/dL.
vii) Creatinin <= 1.2 mg/dL .
viii) CCr >= 60mL/min/body
11) Written informed consent from patient.
Key exclusion criteria 1)Enhanced abdominal CT revealed no Bulky lymph node (>=3cmx1 or >=1.5cmx2).
2)No coagulation disorder.
3)Body temperature >=38 centigrade at the time of enrollment.
4) Active bacterial or fungal infection.
5) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
6) History of hypersensitivity to L-OHP, Fluorouracil, Tegafur, Gimeracil, Oteracilo Potassium, Dexamethason,or 5-HT3 receptor antagonist.
7) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason.
8) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal cancer.
9) Under treatment with flucytosine, phenytoin, or warfarin.
10) Women during pregnancy or breast-feeding.
11) Severe mental disease.
12) Under treatment with systemic steroid.
13) Uncontrollable diabetes mellitus or routine administration of insulin.
14) Uncontrollable hypertension.
15) Active gastrointestinal bleeding.
16) Past history of myocardial infarction or unstable angina pectoris within 6 months.
17) HBs antigen positive.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Katai
Organization National Cancer Center Hospital
Division name Gastric Surgery Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045 Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Honma
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045 Japan
TEL 03-3542-2511
Homepage URL
Email

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 国立がん研究センター中央病院(東京都)
慶応義塾大学病院(東京都)
静岡県立静岡がんセンター(静岡県)
愛知県立がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 31 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
2012 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2016 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 28 Day
Last modified on
2016 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008929

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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