UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007589 |
|---|---|
| Receipt number | 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 18:36:22 |
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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
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
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008929
