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

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 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


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

Value
https://center6.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